FDA Registration
Active
🇫🇷 France
SCIENCE & BIO MATERIALS, S.B.M. SAS
Reg #: 3004549189
·
FEI: 3004051158
·
Expires 2026
Products
12
Proprietary Names
369
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- SCIENCE & BIO MATERIALS, S.B.M. SAS
- Registration Number
- 3004549189
- FEI Number
- 3004051158
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZI DU MONGE
- City
- LOURDES Hautes-Pyrenees
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K151004
Owner / Operator
- Firm Name
- SCIENCE & BIO MATERIALS
- Operator Number
- 9063735
- Address
- S.B.M. SAS - ZI DU MONGE, --
- City
- Lourdes
- State
- Hautes-Pyrenees
- Postal Code
- 65100
- Country
- FR
- Correspondent
- Anne - COSPIN
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street, Suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2015-12-10 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2019-12-05 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2008-09-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-03-06 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2017-12-04 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2020-01-09 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-30 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-01-09 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-08-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-09-14 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2023-08-08 |
Proprietary Names
PULLUP XL adjustable cortical fixation system for ligament reconstruction, Catalog Number PULXL01202
PULLUP adjustable cortical fixation system for ligament reconstruction, Catalog Number PULLU01201
RIGIDLOOP T Adjustable Cortical System - Standard, Catalog Number 232480
RIGIDLOOP T Adjustable Cortical System - XL, Catalog Number 232481
LIGAFIX ratchet tap rod Diameter 7-8 mm, Catalog Number LIG9000319
OTIS-F AO diam.4.5 mm tap, Catalog Number EVO900T868
ComposiTCP 4.5 mm Suture Anchor Punch Tap, Catalog Number 110026111
LIGAFIX Black tap for diam. 8, 9 & 10 mm screws, Catalog Number LIG9000093
ComposiTCP 5.5 mm and 6.5 mm Suture Anchor Punch Tap, Catalog Number 110026112
FIXIT & ecoFIX 5.5 mm and 6.5mm Suture Anchor Punch Tap, Catalog Number EPA9000241
LIGAFIX ratchet tap rod Diameter 9-10-11 mm, Catalog Number LIG9000320
FIXIT & ecoFIX 4.5 mm Suture Anchor Punch Tap, Catalog Number EPA9000240
OTIS-F AO diam. 6.5 mm tap, Catalog Number EVO90T8086
LIGAFIX White tap for diam. 7 mm screws, Catalog Number LIG9000169
BIO 1 Granules for filling - ø 1 mm (2 cm3), Catalog Number P822692243
BIO 1 Sticks for filling - 5 x 5 x 20 mm (5 cm3), Catalog Number P822634444
BIO 1 Sticks for filling - 5 x 5 x 20 mm (10 cm3), Catalog Number P822634445
BIO 1 Granules for filling - ø 1 mm (0.6 cm3), Catalog Number P822692240
BIO 1 Granules for filling - ø 1,5 mm (15 cm3), Catalog Number P822692448
BIO 1 Cubes for filling - 5 x 5 x 5 mm (1.25 cm3), Catalog Number P822693222
BIO 1 Granules for filling - ø 1,5 mm (5 cm3), Catalog Number P822692444
BIO 1 Cubes for filling - 5 x 5 x 5 mm (0.12 cm3), Catalog Number P822693210
BIO 1 Macro-porous cubes for filling - 4 x 4 x 4 mm (15 cm3), Catalog Number P822893229
BIO 1 Granules for filling - ø 3 mm (5 cm3), Catalog Number P822692645
BIO 1 Sticks for filling - 5 x 5 x 10 mm (2.5 cm3), Catalog Number P822634442
BIO 1 Block for filling - 10x10x25 mm (5 cm3), Catalog Number P822694446
BIO 1 Cubes for filling - 10 x 10 x 10 mm (1 cm3), Catalog Number P822693620
BIO 1 Granules for filling - ø 3 mm (10 cm3), Catalog Number P822692647
BIO 1 Cubes for filling - 5 x 5 x 5 mm (0.62 cm3), Catalog Number P822693221
BIO 1 Cubes for filling - 10 x 10 x 10 mm (2 cm3), Catalog Number P822693622
BIO 1 Granules for filling - ø 3 mm (15 cm3), Catalog Number P822692646
BIO 1 Cubes for filling - 7 x 7 x 7 mm (0.34 cm3), Catalog Number P822693420
BIO 1 Granules for filling - ø 1,5 mm (15 cm3), Catalog Number P822692446
BIO 1 Granules for filling - ø 3 mm (5 cm3), Catalog Number P822692644
BIO 1 Cubes for filling - 10 x 10 x 10 mm (10 cm3), Catalog Number P822693624
BIO 1 Cubes for filling - 10 x 10 x 10 mm (5 cm3), Catalog Number P822693623
BIO 1 Cubes for filling - 10 x 10 x 10 mm (15 cm3), Catalog Number P822693626
BIO 1 Granules for filling - ø 3 mm (15 cm3), Catalog Number P822692648
BIO 1 Cubes for filling - 5 x 5 x 5 mm (2.5 cm3), Catalog Number P822693225
BIO 1 Sticks for filling - 5 x 5 x 10 mm (5 cm3), Catalog Number P822634441
BIO 1 Cubes for filling - 5 x 5 x 5 mm (7.5 cm3), Catalog Number P822693227
BIO 1 Cubes for filling - 7 x 7 x 7 mm (1.71 cm3), Catalog Number P822693422
BIO 1 Granules for filling - ø 3 mm (45 cm3), Catalog Number P822692652
BIO 1 Granules for filling - ø 1,5 mm (5 cm3), Catalog Number P822692445
BIO 1 Sticks for filling - 5 x 5 x 20 mm (0.5 cm3), Catalog Number P822634446
BIO 1 Cubes for filling - 7 x 7 x 7 mm (2.40 cm3), Catalog Number P822693426
BIO 1 Sticks for filling - 3 x 3 x 10 mm (0.9 cm3), Catalog Number P822634240
BIO 1 Sticks for filling - 5 x 5 x 10 mm (1.25 cm3, Catalog Number P822634440
BIO 1 Cubes for filling - 7 x 7 x 7 mm (7.20 cm3), Catalog Number P822693428
BIO 1 Block for filling - 10x10x25 mm (2,5 cm3), Catalog Number P822694444
BIO 1 Cubes for filling - 7 x 7 x 7 mm (0.69 cm3), Catalog Number P822693421
Pin Set No. 7 - BTB Rigid Pins, Catalog Number PULLIG9007
LIGAFIX Eyelet pin 2.5 x 400 mm (x10), Catalog Number LIG9000041-10
LIGAFIX Guide pin (K-wire) 2.5 x 300 mm for drill bits (x10), Catalog Number LIG9125300-10
Complete GraftTech preparation station instrumentation set - PULLTAB000
OTIS metallic trial implant - height 15 mm, Catalog Number EVO90FAH15
Pin Set No. 3 - LIGAFIX®/ PULLUP® super-elastic pins, Catalog Number PULLIG9003
ecoPass® L - Suture passer automatic grasper - Shoulder, Catalog Number EPA9000454
Complete MENIX instrumentation set - MEN9000000
ecoPass® non sterile needle (x5), Catalog Number ANS9005461
OTIS metallic trial implant - height 12 mm, Catalog Number EVO90FAH12
Complete RetroTech instrumentation set - PULLFOR001
LIGAFIX Guide pin (K-wire) 2.5 x 300 mm for drill bits (x1), Catalog Number LIG9125300-01
Complete OTIS-F tray - EVO9000000
LIGAFIX Eyelet pin diam. 2.5 mm - L 300 mm X10, Catalog Number LIG9000031-10
LIGAFIX conical stopper, Catalog Number LIG9000267
OTIS metallic trial implant - height 10 mm, Catalog Number EVO90FAH10
Complete set for extremity surgery, Catalog Number EXT9000000
SN-SBM open stripper, Catalog Number LIG9013554
LIGAFIX ratchet screwdriver handle, Catalog Number LIG9000312
LIGAFIX complete Blind Tunnel instrumentation set - LIG90TB000
OTIS impactor tip, Catalog Number EVO9069446
FIXIT / ecoFIX punch diam. 3.5 mm, Catalog Number EPA9000449
LIGAFIX Guide pin (K-wire) 2.5 x 300 mm for drill bits (x5), Catalog Number LIG9125300-05
Pin Set No. 5 - LIGAFIX® super-elastic pins, Catalog Number LIG9000005
Handle for OTIS-F AO tap, Catalog Number EVO90T3741
OTIS-C-PLUS diam. 3.5 mm drill guide, Catalog Number EVO9069428
OTIS metallic trial implant - height 9 mm, Catalog Number EVO90FAH09
MENIX Rasp, Catalog Number MEN9000412
LIGAFIX Super elastic guide pin diam. 0.8 mm-L 400 mm for screwdriver 6-7-8 mm screws X5, Catalog Number LIG9008400-05
Complete OTIS-C-PLUS instrumentation set - EVO90FA800
LIGAFIX Super elastic guide pin ciam. 1.4 mm-L 400 mm X1, Catalog Number LIG9014400-01
OTIS-F AO drill guide, Catalog Number EVO90T4000
Slotted hammer for OTIS metallic trial implants, Catalog Number EVO90FAMAR
LIGAFIX Lanceolate eyelet pin diam. 2.5 mm - L 360 mm X5, Catalog Number LIG9000U36-05
LIGAFIX guide pin sleeve for evolution femoral outside-in aiming device, Catalog Number LIG9000211
Pin Set No. 8 - ST4-ALL PULLUP® rigid pins, Catalog Number PULLUP9008
MENIX 90 Degree Probe, Catalog Number MEN9000408
MENIX Portal Skid, Catalog Number MEN9000397
Complete ecoFIX basket - 1st row - EPA9000005
LIGAFIX Super elastic guide pin diam. 0.8 mm-L 300 mm for screwdriver 6-7-8 mm screws X1, Catalog Number LIG9008300-01
OTIS metallic trial implant - height 11 mm, Catalog Number EVO90FAH11
LIGAFIX Graft gauge - half sizes, Catalog Number LIG9000266
OTIS-C-PLUS & OTIS-F diam. 4.5 mm drill guide, Catalog Number EVO9069430
ecoPass® non sterile needle (x10), Catalog Number ANS9010461
LIGAFIX Eyelet pin 2.5 x 400 mm (x1), Catalog Number LIG9000041-01
OTIS-C-PLUS diam. 3.5 mm round headed temporary screw , Catalog Number EVO9069A45
LIGAFIX Eyelet pin diam. 2.5 mm - L 300 mm X1, Catalog Number LIG9000031-01
OTIS metallic trial implant - height 8 mm, Catalog Number EVO90FAH08
PULLUP Reusable suture retriever pin x1, Catalog Number PUL9000303
RetroTech ring for RetroTech retrograde drill, Catalog Number LIG9018294
OTIS one-piece metallic trial implant - height 7 mm, Catalog Number EVO90FAH07
LIGAFIX Super elastic guide pin ciam. 1.4 mm-L 400 mm X10, Catalog Number LIG9014400-10
Pin Set No. 2 - LIGAFIX®/ PULLUP® rigid pins, Catalog Number PULLIG9002
LIGAFIX Super elastic guide pin diam. 0.8 mm-L 300 mm for screwdriver 6-7-8 mm screws X5, Catalog Number LIG9008300-05
Complete GlenoTech instrumentation set - GLE9000000
LIGAFIX Rigid guide pin 0.9 x 300 mm for screwdriver diam. 6, 7 & 8 mm screws (x10), Catalog Number LIG9109300-10
LIGAFIX Super elastic guide pin diam. 1.4 mm-L 300 mm for screwdriver 9-10-11 mm screws X1, Catalog Number LIG9014300-01
LIGAFIX Lanceolate eyelet pin diam. 2.5 mm - L 360 mm X10, Catalog Number LIG9000U36-10
PULLUP Reusable suture retriever pin x5, Catalog Number PUL9005303
LIGAFIX Lanceolate eyelet pin diam. 2.5 mm - L 360 mm X1, Catalog Number LIG9000U36-01
Complete FIXIT basket 1st + 2nd rows - EPA9000002
LIGAFIX Super elastic guide pin diam. 1.4 mm-L 300 mm for screwdriver 9-10-11 mm screws X5, Catalog Number LIG9014300-05
LIGAFIX Rigid guide pin 1.4 x 300 mm for screwdriver diam. 9, 10 & 11 mm screws (x1), Catalog Number LIG9114300-01
OTIS impactor body, Catalog Number EVO9069444
LIGAFIX evolution femoral outside-In aiming device, Catalog Number LIG9000204
ecoPass® non sterile needle (x1), Catalog Number ANS9001461
ecoPass® S - Suture passer automatic grasper - Knee, Catalog Number MEN9000455
LIGAFIX Super elastic guide pin ciam. 1.4 mm-L 400 mm X5, Catalog Number LIG9014400-05
Pin Set No. 4 - LIGAFIX® rigid pins , Catalog Number LIG9000004
LIGAFIX Rigid guide pin 1.4 x 300 mm for screwdriver diam. 9, 10 & 11 mm screws (x5), Catalog Number LIG9114300-05
LIGAFIX Rigid guide pin Diameter 1.1 mm-L 300 mm (x 5), Catalog Number LIG9111300-05
LIGAFIX Rigid guide pin Diameter 1.1 mm-L 300 mm (x 10), Catalog Number LIG9111300-10
GraftTech preparation station including brackets, Catalog Number PULL000217
LIGAFIX Rigid guide pin 0.9 x 300 mm for screwdriver diam. 6, 7 & 8 mm screws (x5), Catalog Number LIG9109300-05
LIGAFIX Rigid guide pin 1.4 x 300 mm for screwdriver diam. 9, 10 & 11 mm screws (x10), Catalog Number LIG9114300-10
LIGAFIX Rigid guide pin diam. 1.4mm-L 400mm for screwdriver 9-10-11 mm screws X5, Catalog Number LIG9114400-05
SBM closed stripper, Catalog Number LIG90FSTRI
LIGAFIX chondral pick, Catalog Number LIG9000190
LIGAFIX Stopper, Catalog Number LIG9000051
Complete PULLUP-LIGAFIX ligamentoplasty instrumentation set - PULLIG9000
LIGAFIX Eyelet pin diam. 2.5 mm - L 300 mm X5, Catalog Number LIG9000031-05
LIGAFIX Rigid guide pin Diameter 1.1 mm-L 300 mm (x 1), Catalog Number LIG9111300-01
LIGAFIX Super elastic guide pin diam. 0.8 mm-L 400 mm for screwdriver 6-7-8 mm screws X1, Catalog Number LIG9008400-01
LIGAFIX complete Outside Inside instrumentation set - LIG90DD000
OTIS metallic trial implant - height 14 mm, Catalog Number EVO90FAH14
Pin Set No. 1 - PULLUP® pins, Catalog Number PULLUP9001
OTIS one-piece metallic trial implant - height 6 mm, Catalog Number EVO90FAH06
LIGAFIX Rigid guide pin diam. 1.4mm-L 400mm for screwdriver 9-10-11 mm screws X1, Catalog Number LIG9114400-01
LIGAFIX Eyelet pin 2.5 x 400 mm (x5), Catalog Number LIG9000041-05
PULLUP Reusable suture retriever pin x10, Catalog Number PUL9010303
LIGAFIX Pistol-grip femoral aiming device diam. 10 mm, Catalog Number LIG9010B45
LIGAFIX Rigid guide pin diam. 0.9mm-L400 mm for screwdriver 6-7-8 mm screws X10, Catalog Number LIG9109400-10
Complete ecoFIX basket - 1st and 2nd rows - EPA9000007
LIGAFIX diameter 2.5 mm drill guide, Catalog Number LIG9000264
LIGAFIX Rigid guide pin diam. 0.9mm-L400 mm for screwdriver 6-7-8 mm screws X1, Catalog Number LIG9109400-01
LIGAFIX Rigid guide pin diam. 1.4mm-L 400mm for screwdriver 9-10-11 mm screws X10, Catalog Number LIG9114400-10
FIXIT Reusable suture retriever pin, Catalog Number EPA9000303
RetroTech drill guide, Catalog Number LIG9000424
Handles for OTIS metallic trial implants, Catalog Number EVO90FAMAN
Complete FIXIT basket 1st row - EPA9000001
LIGAFIX Super elastic guide pin diam. 0.8 mm-L 400 mm for screwdriver 6-7-8 mm screws X10, Catalog Number LIG9008400-10
LIGAFIX diameter 4.5 mm drill guide, Catalog Number LIG9000215
MENIX Knot Pusher, Catalog Number MEN9000400
MENIX Twister, Catalog Number MEN9000402
LIGAFIX Rigid guide pin diam. 0.9mm-L400 mm for screwdriver 6-7-8 mm screws X5, Catalog Number LIG9109400-05
OTIS-C-PLUS depth gauge, Catalog number EVO9069438
Complete LIGAFIX-PULLUP instrumentation set, Catalog Number LIG90DT001
LIGAFIX Rigid guide pin 0.9 x 300 mm for screwdriver diam. 6, 7 & 8 mm screws (x1), Catalog Number LIG9109300-01
LIGAFIX Super elastic guide pin diam. 1.4 mm-L300 mm for screwdriver 9-10-11 mm screws X10, Catalog Number LIG9014300-10
Complete OTIS instrumentation set for HTO - EVO90FA500
LIGAFIX Guide pin introducer for rigid guide pin diam. 0.9 mm, Catalog Number LIG9000092
LIGAFIX Super elastic guide pin diam. 0.8 mm-L 300 mm for screwdriver 6-7-8 mm screws X10, Catalog Number LIG9008300-10
FIXIT / ecoFIX Mallet, Catalog Number EPA9000247
Complete PULLUP ligamentoplasty instrumentation set - PULL900000
OTIS metallic trial implant - height 13 mm, Catalog Number EVO90FAH13
LIGAFIX tibial aiming device-evolution, Catalog Number LIG9000214
LIGAFIX Pistol-grip femoral aiming device diam. 9 mm, Catalog Number LIG9009B45
OTIS 50 implant - Height 11mm, Catalog Number P822667232
OTIS 50 implant - Height 12mm, Catalog Number P822667234
OTIS 50 implant - Height 15mm, Catalog Number P822667240
OTIS implant - Height 8mm, Catalog Number P822365226
OTIS implant - Height 14mm, Catalog Number P822365238
OTIS 50 implant - Height 10mm, Catalog Number P822667230
OTIS 50 implant - Height 9mm, Catalog Number P822667228
OTIS 50 implant - Height 13mm, Catalog Number P822667236
OTIS implant - Height 10mm, Catalog Number P822365230
OTIS implant - Height 7mm, Catalog Number P822365224
OTIS 50 implant - Height 8mm, Catalog Number P822667226
OTIS implant - Height 15mm, Catalog Number P822365240
OTIS 50 implant - Height 14mm, Catalog Number P822667238
OTIS implant - Height 6mm, Catalog Number P822365222
OTIS implant - Height 11mm, Catalog Number P822365232
OTIS 50 implant - Height 6mm, Catalog Number P822667222
OTIS implant - Height 13mm, Catalog Number P822365236
OTIS implant - Height 9mm, Catalog Number P822365228
OTIS implant - Height 12mm, Catalog Number P822365234
OTIS 50 implant - Height 7mm, Catalog Number P822667224
PULLUP CLIP connectable plate, Catalog Number PULL0CT201
PULLUP TEX CLIP loop only, Catalog Number PULL00LOOP
PULLUP adjustable fixation system for ligament reconstruction, Catalog Number PULLU01201
PULLUP XL adjustable fixation system for ligament reconstruction, Catalog Number PULXL01202
PULLUP XL CLIP connectable plate, Catalog Number PULXLCT202
BTLOOP adjustable fixation system for ligament reconstruction, Catalog Number BTB0001709
BTLOOP XL adjustable fixation system for ligament reconstruction, Catalog Number BTBXL01709
FIXIT Knotless 4.5 mm threaded anchor single interference, Catalog Number EPAV245KNO
FIXIT 5.5 mm threaded anchor mounted on screwdriver, Catalog Number EPA0055CLA
FIXIT 6.5 mm threaded anchor mounted on screwdriver, Catalog Number EPA0065CLA
ComposiTCP 6.5 mm Double Loaded MaxBraid Suture Anchor, Catalog Number 110026107
FIXIT 4.5 mm threaded anchor mounted on screwdriver, Catalog Number EPA0047CLA
FIXIT Knotless 6.5 mm threaded anchor single interference, Catalog Number EPAV265KNO
FIXIT Knotless 5.5 mm threaded anchor single interference, Catalog Number EPAV255KNO
ComposiTCP 4.5 mm Double Loaded MaxBraid Suture Anchor, Catalog Number 110026105
ComposiTCP 5.5 mm Double Loaded MaxBraid Suture Anchor, Catalog Number 110026106
PULLUP Cutting Pliers, Catalog Number PULL000219
MENIX Arthroscopic Scissors, Catalog Number MEN9000406
MENIX Suture Cutter, Catalog Number MEN9000398
ComposiTCP 60 interference screw, Catalog Number 905256
LIGAFIX® 30 interference screw, Catalog Number COM3007P20
ComposiTCP 30 interference screw, Catalog Number 110004612
LIGAFIX® 60 interference screw, Catalog Number COM6010030
LIGAFIX® 60 interference screw, Catalog Number COM6008030
ComposiTCP 60 interference screw, Catalog Number 905264
LIGAFIX® 30 interference screw, Catalog Number COM3011030
LIGAFIX® 30 interference screw, Catalog Number COM3008020
LIGAFIX® 60 interference screw, Catalog Number COM6010035
ComposiTCP 30 interference screw, Catalog Number 110004594
ComposiTCP 60 interference screw, Catalog Number 905257
ComposiTCP 30 interference screw, Catalog Number 110004609
LIGAFIX® 30 interference screw, Catalog Number COM3007P25
LIGAFIX® 30 interference screw, Catalog Number COM3008030
ComposiTCP 60 interference screw, Catalog Number 905263
LIGAFIX® 60 interference screw, Catalog Number COM6009020
LIGAFIX® 60 interference screw, Catalog Number COM6010R25
LIGAFIX® 30 interference screw, Catalog Number COM3007030
ComposiTCP 30 interference screw, Catalog Number 110004598
LIGAFIX® 30 interference screw, Catalog Number COM3008025
LIGAFIX® 30 interference screw, Catalog Number COM3009P25
LIGAFIX® 60 interference screw, Catalog Number COM6008025
LIGAFIX® 30 interference screw, Catalog Number COM3007020
ComposiTCP 30 interference screw, Catalog Number 905217
ComposiTCP 30 interference screw, Catalog Number 110004611
ComposiTCP 60 interference screw, Catalog Number 905262
ComposiTCP 30 interference screw, Catalog Number 110004605
ComposiTCP 60 interference screw, Catalog Number 905258
LIGAFIX® 30 interference screw, Catalog Number COM3010R35
ComposiTCP 30 interference screw, Catalog Number 110004608
LIGAFIX® 60 interference screw, Catalog Number COM6009030
ComposiTCP 30 interference screw, Catalog Number 905216
LIGAFIX® 60 interference screw, Catalog Number COM6010R30
LIGAFIX® 60 interference screw, Catalog Number COM6007025
LIGAFIX® 60 interference screw, Catalog Number COM6008020
ComposiTCP 30 interference screw, Catalog Number 905218
LIGAFIX® 60 interference screw, Catalog Number COM6007030
LIGAFIX® 60 interference screw, Catalog Number COM6009025
LIGAFIX® 30 interference screw, Catalog Number COM3009030
ComposiTCP 30 interference screw, Catalog Number 110004595
ComposiTCP 60 interference screw, Catalog Number 905259
ComposiTCP 30 interference screw, Catalog Number 110004599
ComposiTCP 60 interference screw, Catalog Number 905261
LIGAFIX® 60 interference screw, Catalog Number COM6009035
ComposiTCP 30 interference screw, Catalog Number 110004604
LIGAFIX® 30 interference screw, Catalog Number COM3010R30
LIGAFIX® 30 interference screw, Catalog Number COM3009020
LIGAFIX® 30 interference screw, Catalog Number COM3008P25
LIGAFIX® 60 interference screw, Catalog Number COM6007020
LIGAFIX® 30 interference screw, Catalog Number COM3008P20
LIGAFIX® 30 interference screw, Catalog Number COM3009035
LIGAFIX® 30 interference screw, Catalog Number COM3010030
LIGAFIX® 30 interference screw, Catalog Number COM3007025
LIGAFIX® 30 interference screw, Catalog Number COM3009025
LIGAFIX® 60 interference screw, Catalog Number COM6011035
LIGAFIX® 30 interference screw, Catalog Number COM3011035
LIGAFIX® 60 interference screw, Catalog Number COM6011030
LIGAFIX® 30 interference screw, Catalog Number COM3010R25
OTIS-C-PLUS plate - Left, Catalog Number EVO9067722
OTIS-C-PLUS plate - Right, Catalog Number EVO9067522
OTIS self-tapping locking screw - length 60 mm, Catalog Number EVO9066060
OTIS self-tapping locking screw - length 33 mm, Catalog Number EVO9066033
OTIS self-tapping locking screw - length 39 mm, Catalog Number EVO9066039
OTIS self-tapping locking screw - length 27 mm, Catalog Number EVO9066027
OTIS self-tapping locking screw - length 65 mm, Catalog Number EVO9066065
OTIS self-tapping locking screw - length 55 mm, Catalog Number EVO9066055
OTIS self-tapping locking screw - length 30 mm, Catalog Number EVO9066030
OTIS self-tapping locking screw - length 42 mm, Catalog Number EVO9066042
OTIS self-tapping locking screw - length 50 mm, Catalog Number EVO9066050
OTIS self-tapping locking screw - length 70 mm, Catalog Number EVO9066070
OTIS self-tapping locking screw - length 45 mm, Catalog Number EVO9066045
OTIS self-tapping locking screw - length 36 mm, Catalog Number EVO9066036
LIGAFIX diameter 6.5 mm router bit, Catalog Number LIG9065072
LIGAFIX diameter 10 mm router bit, Catalog Number LIG9010072
LIGAFIX diameter 11 mm router bit, Catalog Number LIG9011072
LIGAFIX L 60 mm - diameter 11 mm cannulated drill bit, long flute, Catalog Number LIG9011289
LIGAFIX L 60 mm - diameter 6 mm cannulated drill bit, long flute, Catalog Number LIG9006289
LIGAFIX L 60 mm - diameter 7 mm cannulated drill bit, long flute, Catalog Number LIG9007289
LIGAFIX L 60 mm - diameter 9 mm cannulated drill bit, long flute, Catalog Number LIG9009289
LIGAFIX diameter 7 mm router bit, Catalog Number LIG9070072
LIGAFIX diameter 10.5 mm router bit, Catalog Number LIG9010572
LIGAFIX diameter 7.5 mm router bit, Catalog Number LIG9075072
LIGAFIX diameter 9 mm router bit, Catalog Number LIG9090072
LIGAFIX L 60 mm - diameter 8.5 mm cannulated drill bit, long flute, Catalog Number LIG9085289
LIGAFIX diameter 8 mm router bit, Catalog Number LIG9080072
PULLUP diameter 4.5 mm cannulated drill bit, Catalog Number PULL000255
LIGAFIX L 60 mm - diameter 6.5 mm cannulated drill bit, long flute, Catalog Number LIG9065289
LIGAFIX diameter 4.5 mm non-cannulated drill bit, Catalog Number LIG9045FOR
OTIS-C-PLUS countersink bit, Catalog Number EVO9040203
RetroTech diam. 4.7 mm cannulated drill bit, Catalog Number PULL000391
LIGAFIX diameter 8.5 mm router bit, Catalog Number LIG9085072
LIGAFIX L 60 mm - diameter 7.5 mm cannulated drill bit, long flute, Catalog Number LIG9075289
LIGAFIX L 60 mm - diameter 9.5 mm cannulated drill bit, long flute, Catalog Number LIG9095289
LIGAFIX diameter 9.5 mm router bit, Catalog Number LIG9095072
OTIS-F AO diam. 3.2 mm - L 145 mm drill bit, Catalog Number EVO900T878
GlenoTech diameter 5 mm cannulated drill bit, Catalog Number GLE9000426
LIGAFIX L 60 mm - diameter 10 mm cannulated drill bit, long flute, Catalog Number LIG9010289
LIGAFIX L 60 mm - diameter 8 mm cannulated drill bit, long flute, Catalog Number LIG9008289
LIGAFIX L 60 mm - diameter 10.5 mm cannulated drill bit, long flute, Catalog Number LIG9105289
OTIS-C-PLUS diam. 4.5 mm drill - length 195 mm, Catalog Number EVO9069434
OTIS-C-PLUS diam. 3 mm drill for temporary screw, Catalog Number EVO9035100
OTIS-C-PLUS diam. 3.5 mm drill - length 195 mm, Catalog Number EVO9069432
RetroTech retrograde drill, Catalog Number LIG9000294
Drill bit diameter 4 mm - length 450 mm, Catalog Number EVO9069433
ComposiTCP 4.5 mm Double Loaded BroadBand Suture Anchor, Catalog Number 110026108
ComposiTCP 6.5 mm Non-Sliding BroadBand Suture Anchor, Catalog Number 110026115
ComposiTCP 4.5 mm Non-Sliding BroadBand Suture Anchor, Catalog Number 110026113
FIXIT® Band 6.5 mm threaded anchor mounted on screwdriver, Catalog Number EPABR65CLA
FIXIT® Band 5.5 mm threaded anchor mounted on screwdriver, Catalog Number EPABR55CLA
ComposiTCP 5.5 mm Double Loaded BroadBand Suture Anchor, Catalog Number 110026109
ComposiTCP 5.5 mm Non-Sliding BroadBand Suture Anchor, Catalog Number 110026114
ComposiTCP 6.5 mm Double Loaded BroadBand Suture Anchor, Catalog Number 110026110
FIXIT® Band 4.5 mm threaded anchor mounted on screwdriver, Catalog Number EPABR47CLA
ComposiTCP Modular Driver, Catalog Number 110004607
LIGAFIX green screwdriver for 7 & 8 mm screws, Catalog Number LIG9008046
ecoFIX diameter 5.5-6.5 mm Screwdriver, Catalog Number EPA9000403
ecoFIX diameter 4.5 mm Screwdriver, Catalog Number EPA9000401
ComposiTCP Modular Driver, Catalog Number 905274
OTIS-C-PLUS diam. 3.5 mm hexagonal screwdriver, Catalog Number EVO9069436
LIGAFIX blue screwdriver for 9, 10 & 11 mm screws, Catalog Number LIG9009017
FIXIT Knotless / ecoFIX Knotless Screwdriver, Catalog Number EPA9000315
Screwdriver for OTIS screw extraction, Catalog Number EVO9069439
LIGAFIX ratchet screwdriver rod Diameter 9-10-11 mm, Catalog Number LIG9000311
LIGAFIX ratchet screwdriver rod Diameter 7-8 mm, Catalog Number LIG9000310
ComposiTCP interference screws
FIXIT® & ecoFIX® cleaning and sterilization basket, Catalog Number EPA9000101
GraftTech® cleaning and sterilization basket, Catalog Number PULLTAB001
LIGAFIX® - PULLUP® cleaning and sterilization basket, Catalog Number PULLIGPA02
OTIS-F® tray, Catalog Number EVO9080000
RetroTech® cleaning and sterilization basket, Catalog Number PANIERETRO
250 x 250 sterilization basket with silicone mat, Catalog Number PULLIGPA03
250 X 250 sterilization basket lid, Catalog Number PULLIGPA04
OTIS® cleaning and sterilization basket, Catalog Number EVO90FA222
MENIX® cleaning and sterilization basket, Catalog Number MEN9000001
OTIS-C-PLUS® cleaning and sterilization basket, Catalog Number EVO90FA700
ecoFIX® Needle diameter 6.5 mm Threaded Double-Loaded Suture Anchor System with Needles ; Catalog Number EPAV365CLA
ecoFIX® diameter 5.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV255CLA
ecoFIX® Knotless diameter 4.5 mm Threaded Anchor ; Catalog Number EPAV345KNO
ecoFIX® Band diameter 4.5 mm Threaded Double-Loaded Flat Suture Anchor System ; Catalog Number EPAV545CLA
ecoFIX® diameter 6.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV265CLA
ecoFIX® Needle diameter 4.5 mm Threaded Double-Loaded Suture Anchor System with Needles ; Catalog Number EPAV345CLA
ecoFIX® + diameter 5.5 mm Threaded Triple-Loaded Suture Anchor System ; Catalog Number EPAV455CLA
ecoFIX® Band diameter 5.5 mm Threaded Double-Loaded Flat Suture Anchor System ; Catalog Number EPAV555CLA
ecoFIX® Knotless diameter 5.5 mm Threaded Anchor ; Catalog Number EPAV355KNO
ecoFIX® Needle diameter 5.5 mm Threaded Double-Loaded Suture Anchor System with Needles ; Catalog Number EPAV355CLA
ecoFIX® Band diameter 6.5 mm Threaded Double-Loaded Flat Suture Anchor System ; Catalog Number EPAV565CLA
ecoFIX® diameter 4.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV245CLA
ecoFIX® Knotless diameter 6.5 mm Threaded Anchor ; Catalog Number EPAV365KNO
MENIX® Meniscal Suture System, 1 anchor ; Catalog Number MEN0201902
MENIX® DUO Meniscal Suture System, 2 anchors ; Catalog Number MEN0201901
RIGIDLOOP Clip Cortical Button - XL, Catalog Number 232483
RIGIDLOOP Clip Cortical Button - Standard, Catalog Number 232482
RIGIDLOOP Suture Loop, Catalog Number 232484
BT LOOP® XL Adjustable fixation system for ligament reconstruction, tunnel diam. 5-10mm, Catalog Number BTBXL01709
PULLUP® BTB Adjustable fixation system for ligament reconstruction - tunnel diam. 4.5mm, Catalog Number PULLUK1201
RIGIDLOOP BTB Adjustable Cortical System - XL, Catalog Number 232486
PULLUP® CLIP connectable plate - tunnel diam. 4.5mm, Catalog Number PULL0CT201
BT LOOP® Adjustable fixation system for ligament reconstruction, tunnel diam. 4.5mm, Catalog Number BTB0001709
RIGIDLOOP BTB Adjustable Cortical System - Standard, Catalog Number 232485
PULLUP® XL CLIP connectable plate - tunnel diam. 5-10mm, Catalog Number PULXLCT202
PULLUP® TEX CLIP Adjustable fixation system for ligament reconstruction - loop only, Catalog Number PULL00LOOP
PULLUP® BTB XL Adjustable fixation system for ligament reconstruction - tunnel diam. 5-10mm, Catalog Number PULXLK1202
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device