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Ligafix®
EUDAMEDFDA UDIClass I (EU MDR)
Ref LIG9000169Model Bone tapRef LIG9000031-01Model PinRef LIG9109400-10Ref LIG9109300-01Ref LIG9000U36-01
by S.b.m. Sas
Identity
- Trade Name
- LIGAFIX® EUDAMEDLIGAFIX FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDIBone tap, reusable FDA UDI
- Device Name
- Bone tap for ACL reconstruction EUDAMEDPin for ACL reconstruction EUDAMEDLanceolate eyelet pin Ø 2.5 mm - L 360 mm X1 to be used with LIGAFIX interference screws for ACL reconstruction. FDA UDIRigid guide pin Ø 0.9 mm - L 300 mm to be used with LIGAFIX screwdriver for interference screws of diameter 6, 7 and 8 mm in ACL reconstruction. 1 unit per package FDA UDIBlack tap to be used with LIGAFIX interference screws of diameter 7 mm, for ACL reconstruction. FDA UDIRigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction. FDA UDI
- Model / Reference
- Bone tap EUDAMEDLIG9000169 EUDAMEDPin EUDAMEDLIG9000031-01 EUDAMEDLIG9109400-10 EUDAMEDLIG9109300-01 EUDAMEDLIG9000U36-01 EUDAMEDLanceolate eyelet pin X1 FDA UDIRigid guide pin X1 FDA UDIBlack tap for Ø 7 mm screws FDA UDIRigid guide pin X10 FDA UDI
- Description
- Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X1 to be used with LIGAFIX interference screws for ACL reconstruction. FDA UDIRigid guide pin Ø 0.9 mm - L 300 mm to be used with LIGAFIX screwdriver for interference screws of diameter 6, 7 and 8 mm in ACL reconstruction. 1 unit per package FDA UDIBlack tap to be used with LIGAFIX interference screws of diameter 7 mm, for ACL reconstruction. FDA UDIRigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction. FDA UDI
Identifiers
- Catalog Number
- LIG9000U36-01 FDA UDILIG9109300-01 FDA UDILIG9000169 FDA UDILIG9109400-10 FDA UDI
- Primary DI / UDI-DI
- 03760154002271 EUDAMEDFDA UDI03760154005739 EUDAMEDFDA UDI03760154006101 EUDAMEDFDA UDI03760154002578 EUDAMEDFDA UDI03760154002509 EUDAMED
- Basic UDI-DI
- 376015400DT2019046VT EUDAMED376015400DT201904105H EUDAMED
- FDA Product Code
- LXH FDA UDIHWX FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDIBone tap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France EUDAMEDSpain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.5 Millimeter FDA UDILength — 360 Millimeter FDA UDIOuter Diameter — 0.9 Millimeter FDA UDILength — 300 Millimeter FDA UDILength — 400 Millimeter FDA UDI
Category: Surgical implant template, reusable
Ligafix® by S.b.m. Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376015400DT2019046VT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.b.m. Sas
- EUDAMED SRN
- FR-MF-000000214
Sources (9)
- EUDAMED 5a34a996-283d-4c2b-85d9-50a0889a3f8d 61 fields · synced Jul 29, 2026
- FDA UDI c1463366-f5df-4f54-8832-95072b5de6e9 35 fields · synced May 27, 2026
- FDA UDI 91ac6a9c-3c6e-4313-9624-bafdf0d2fc80 35 fields · synced May 27, 2026
- FDA UDI 59337bbd-d12d-4ff8-a8e7-083ed135ed4f 34 fields · synced May 30, 2026
- FDA UDI e9a69c97-e33f-4bbe-b4a4-5a132dcf5243 35 fields · synced May 30, 2026
- EUDAMED 195058fc-53ea-47c2-bce6-f778bb39202d 61 fields · synced Jul 9, 2026
- EUDAMED 01467db0-7f47-4304-9b5b-21a75ede2850 61 fields · synced Jul 15, 2026
- EUDAMED 07784afd-676c-42b8-ae2c-56900e82b7b5 61 fields · synced Jul 23, 2026
- EUDAMED 5937f2f5-e4ff-4663-8495-fc8f0202b52a 61 fields · synced Jul 24, 2026