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
Phone
786 7311159

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

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