Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004549189

FEI Number

3004051158

Entity Name

SCIENCE & BIO MATERIALS, S.B.M. SAS

City/State/Country

LOURDES Hautes-Pyrenees, FR

Establishment Address

ZI DU MONGE, LOURDES Hautes-Pyrenees 65100, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

SCIENCE & BIO MATERIALS (Owner Number: 9063735)

Owner / Operator Contact Address

S.B.M. SAS - ZI DU MONGE, --, Lourdes, FR-65 65100, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223122

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-12-10
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2019-12-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-09-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2006-03-06
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-11-20
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2017-12-04
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2020-01-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-01-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-07-30
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2019-08-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-09-14
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-08

Official Correspondent

Anne COSPIN

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: Stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

SCIENCE & BIO MATERIALS

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
1219930	Covidien	North Haven, CT, US
3016660811	SUBCHONDRAL SOLUTIONS	Costa Mesa, CA, US
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004549189. Last updated year: 2026. Please use registration number 3004549189 when referencing this establishment in official correspondence.