Identity
- Trade Name
- Bilok® Screw FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible. FDA UDI
- Model / Reference
- 160-830T FDA UDI
- Description
- The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible. FDA UDI
Identifiers
- Catalog Number
- 160-830T FDA UDI
- Primary DI / UDI-DI
- 15060155710584 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 8 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Category: Bioabsorbable orthopaedic bone screw
Bilok® Screw by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biocomposites Ltd
Sources (1)
- FDA UDI 4ffcaadf-7167-447c-89c7-8a63b4e4088f 37 fields · synced May 30, 2026