FDA Registration
Active
🇫🇷 France
LIGAFIX Rigid guide pin Diameter 1.1 mm - L 300 mm (x 1), Catalog Number LIG9111300-01
Reg #: 3004549189
·
FEI: 3004051158
·
Expires 2025
Products
1
Proprietary Names
108
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SCIENCE & BIO MATERIALS, S.B.M. SAS
- Registration Number
- 3004549189
- FEI Number
- 3004051158
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZI DU MONGE
- City
- LOURDES Hautes-Pyrenees
- Country
- FR
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-03-06 |
Proprietary Names
LIGAFIX Rigid guide pin Diameter 1.1 mm - L 300 mm (x 1), Catalog Number LIG9111300-01
Non sterile needle (x1), Catalog Number ANS9001461
Suture passer automatic grasper - Knee, Catalog Number MEN9000455
LIGAFIX tibial aiming device-evolution, Catalog Number LIG9000214
LIGAFIX guide pin sleeve for evolution femoral outside-in aiming device, Catalog Number LIG9000211
LIGAFIX Pistol-grip femoral aiming device diam. 10 mm, Catalog Number LIG9010B45
LIGAFIX Super elastic guide pin ciam. 1.4 mm - L 400 mm X5, Catalog Number LIG9014400-05
LIGAFIX Rigid guide pin 0.9 x 300 mm for screwdriver diam. 6, 7 & 8 mm screws (x5), Catalog Number LIG9109300-05
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 (x1), Catalog Number LIG9125300-01
OTIS one-piece metallic trial implant - height 6 mm, Catalog Number EVO90FAH06
LIGAFIX Lanceolate eyelet pin diam. 2.5 mm - L 360 mm X5, Catalog Number LIG9000U36-05
LIGAFIX Super elastic guide pin diam. 0.8 mm - L 300 mm for screwdriver 6-7-8 mm screws X1, Catalog Number LIG9008300-01
FIXIT / ecoFIX Mallet, Catalog Number EPA9000247
OTIS metallic trial implant - height 8 mm, Catalog Number EVO90FAH08
LIGAFIX Super elastic guide pin diam. 0.8 mm - L 400 mm for screwdriver 6-7-8 mm screws X5, Catalog Number LIG9008400-05
MENIX 90 Degree Probe, Catalog Number MEN9000408
PULLUP Reusable suture retriever pin, Catalog Number PUL9000303
LIGAFIX Super elastic guide pin ciam. 1.4 mm - L 400 mm X10, Catalog Number LIG9014400-10
Handles for OTIS metallic trial implants, Catalog Number EVO90FAMAN
LIGAFIX Eyelet pin diam. 2.5 mm - L 300 mm X10, Catalog Number LIG9000031-10
OTIS-C-PLUS diam. 3.5 mm drill guide, Catalog Number EVO9069428
OTIS one-piece metallic trial implant - height 7 mm, Catalog Number EVO90FAH07
LIGAFIX Rigid guide pin diam. 1.4mm - L 400mm for screwdriver 9-10-11 mm screws X5, Catalog Number LIG9114400-05
LIGAFIX Stopper, Catalog Number LIG9000051
LIGAFIX Guide pin introducer for rigid guide pin diam. 0.9 mm, Catalog Number LIG9000092
LIGAFIX Rigid guide pin 0.9 x 300 mm for screwdriver diam. 6, 7 & 8 mm screws (x10), Catalog Number LIG9109300-10
OTIS complete instrumentation set for HTO - EVO90FA500
LIGAFIX Guide pin (K-wire) 2.5 x 300 mm for drill bits (x5), Catalog Number LIG9125300-05
OTIS-C-PLUS diam. 3.5 mm round headed temporary screw , Catalog Number EVO9069A45
LIGAFIX Super elastic guide pin diam. 0.8 mm - L 300 mm for screwdriver 6-7-8 mm screws X5, Catalog Number LIG9008300-0
MENIX Portal Skid, Catalog Number MEN9000397
LIGAFIX Lanceolate eyelet pin diam. 2.5 mm - L 360 mm X10, Catalog Number LIG9000U36-10
Complete FIXIT basket 1st row - EPA9000001
Complete OTIS-F tray - EVO9000000
LIGAFIX Graft gauge - half sizes, Catalog Number LIG9000266
LIGAFIX Rigid guide pin 1.4 x 300 mm for screwdriver diam. 9, 10 & 11 mm screws (x10), Catalog Number LIG9114300-10
MENIX Twister, Catalog Number MEN9000402
OTIS-C-PLUS depth gauge, Catalog number EVO9069438
LIGAFIX-PULLUP complete instrumentation set, Catalog Number LIG90DT001
Slotted hammer for OTIS metallic trial implants, Catalog Number EVO90FAMAR
LIGAFIX Super elastic guide pin diam. 0.8 mm - L 300 mm for screwdriver 6-7-8 mm screws X10, Catalog Number LIG9008300-1
LIGAFIX Eyelet pin diam. 2.5 mm - L 300 mm X1, Catalog Number LIG9000031-01
SN-SBM open stripper, Catalog Number LIG9013554
OTIS-C-PLUS complete instrumentation set - EVO90FA800
GlenoTech complete instrumentation set - GLE9000000
MENIX complete instrumentation set - MEN9000000
LIGAFIX chondral pick, Catalog Number LIG9000190
OTIS impactor tip, Catalog Number EVO9069446
LIGAFIX Eyelet pin 2.5 x 400 mm (x5), Catalog Number LIG9000041-05
LIGAFIX Rigid guide pin diam. 0.9mm - L400 mm for screwdriver 6-7-8 mm screws X10, Catalog Number LIG9109400-10
LIGAFIX Guide pin (K-wire) 2.5 x 300 mm for drill bits (x10), Catalog Number LIG9125300-10
OTIS-C-PLUS & OTIS-F diam. 4.5 mm drill guide, Catalog Number EVO9069430
OTIS metallic trial implant - height 9 mm, Catalog Number EVO90FAH09
OTIS metallic trial implant - height 13 mm, Catalog Number EVO90FAH13
LIGAFIX Super elastic guide pin diam. 0.8 mm - L 400 mm for screwdriver 6-7-8 mm screws X1, Catalog Number LIG9008400-01
Handle for OTIS-F AO tap, Catalog Number EVO90T3741
OTIS impactor body, Catalog Number EVO9069444
MENIX Rasp, Catalog Number MEN9000412
FIXIT Reusable suture retriever pin, Catalog Number EPA9000303
LIGAFIX conical stopper, Catalog Number LIG9000267
LIGAFIX diameter 4.5 mm drill guide, Catalog Number LIG9000215
LIGAFIX Eyelet pin diam. 2.5 mm - L 300 mm X5, Catalog Number LIG9000031-05
LIGAFIX Lanceolate eyelet pin diam. 2.5 mm - L 360 mm X1, Catalog Number LIG9000U36-01
OTIS metallic trial implant - height 10 mm, Catalog Number EVO90FAH10
LIGAFIX Rigid guide pin diam. 0.9mm - L400 mm for screwdriver 6-7-8 mm screws X5, Catalog Number LIG9109400-05
LIGAFIX diameter 2.5 mm drill guide, Catalog Number LIG9000264
FIXIT / ecoFIX punch diam. 3.5 mm, Catalog Number EPA9000449
LIGAFIX Rigid guide pin 1.4 x 300 mm for screwdriver diam. 9, 10 & 11 mm screws (x5), Catalog Number LIG9114300-05
PULLUP-LIGAFIX complete ligamentoplasty instrumentation set - PULLIG9000
RetroTech drill guide, Catalog Number LIG9000424
RetroTech complete instrumentation set - PULLFOR001
LIGAFIX complete Blind Tunnel instrumentation set - LIG90TB000
OTIS-F AO drill guide, Catalog Number EVO90T4000
LIGAFIX Eyelet pin 2.5 x 400 mm (x1), Catalog Number LIG9000041-01
LIGAFIX evolution femoral outside-In aiming device, Catalog Number LIG9000204
LIGAFIX ratchet screwdriver handle, Catalog Number LIG9000312
Non sterile needle (x5), Catalog Number ANS9005461
LIGAFIX Super elastic guide pin diam. 0.8 mm - L 400 mm for screwdriver 6-7-8 mm screws X10, Catalog Number LIG9008400-1
Non sterile needle (x10), Catalog Number ANS9010461
LIGAFIX Rigid guide pin Diameter 1.1 mm - L 300 mm (x 5), Catalog Number LIG9111300-05
LIGAFIX Super elastic guide pin diam. 1.4 mm - L300 mm for screwdriver 9-10-11 mm screws X10, Catalog Number LIG9014300-
LIGAFIX Rigid guide pin diam. 0.9mm - L400 mm for screwdriver 6-7-8 mm screws X1, Catalog Number LIG9109400-01
LIGAFIX complete Outside Inside instrumentation set - LIG90DD000
LIGAFIX Rigid guide pin Diameter 1.1 mm - L 300 mm (x 10), Catalog Number LIG9111300-10
LIGAFIX Rigid guide pin 0.9 x 300 mm for screwdriver diam. 6, 7 & 8 mm screws (x1), Catalog Number LIG9109300-01
LIGAFIX Rigid guide pin 1.4 x 300 mm for screwdriver diam. 9, 10 & 11 mm screws (x1), Catalog Number LIG9114300-01
LIGAFIX Pistol-grip femoral aiming device diam. 9 mm, Catalog Number LIG9009B45
LIGAFIX Super elastic guide pin diam. 1.4 mm - L 300 mm for screwdriver 9-10-11 mm screws X1, Catalog Number LIG9014300-
Complete ecoFIX basket - 1st row - EPA9000005
Suture passer automatic grasper - Shoulder, Catalog Number EPA9000454
GraftTech preparation station including brackets, Catalog Number PULL000217
LIGAFIX Super elastic guide pin diam. 1.4 mm - L 300 mm for screwdriver 9-10-11 mm screws X5, Catalog Number LIG9014300-
RetroTech ring for RetroTech retrograde drill, Catalog Number LIG9018294
OTIS metallic trial implant - height 11 mm, Catalog Number EVO90FAH11
LIGAFIX Rigid guide pin diam. 1.4mm - L 400mm for screwdriver 9-10-11 mm screws X1, Catalog Number LIG9114400-01
OTIS metallic trial implant - height 14 mm, Catalog Number EVO90FAH14
MENIX Knot Pusher, Catalog Number MEN9000400
LIGAFIX Super elastic guide pin ciam. 1.4 mm - L 400 mm X1, Catalog Number LIG9014400-01
OTIS metallic trial implant - height 15 mm, Catalog Number EVO90FAH15
LIGAFIX Rigid guide pin diam. 1.4mm - L 400mm for screwdriver 9-10-11 mm screws X10, Catalog Number LIG9114400-10
OTIS metallic trial implant - height 12 mm, Catalog Number EVO90FAH12
SBM closed stripper, Catalog Number LIG90FSTRI
Complete ecoFIX basket - 1st and 2nd rows - EPA9000007
Complete FIXIT basket 1st + 2nd rows - EPA9000002
PULLUP ligamentoplasty complete instrumentation set - PULL900000
Complete set for extremity surgery, Catalog Number EXT9000000
GraftTech preparation station complete instrumentation set - PULLTAB000
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device