Identity
- Trade Name
- B-screw TCP FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Model / Reference
- Ø08 L30 FDA UDI
Identifiers
- Catalog Number
- 730830NGD01 FDA UDI
- Primary DI / UDI-DI
- 03701505800962 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
FDA UDI
Category: Bioabsorbable orthopaedic bone screw
B-screw TCP by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioabsorbable orthopaedic bone screw.
- MILAGRO — DePuy Mitek, Inc. · Class II
- ActivaScrew™ — Bioretec Oy · Class II
- MILAGRO — Medos International Sàrl · Class II
- 1.5 mm Inion CPS® Baby — Inion , Ltd. · Class II
- Inion Hexalon™ — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- MILAGRO — Medos International Sàrl · Class II
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
- Teknimed
Sources (1)
- FDA UDI 31391332-c285-41c6-97f3-af915f2c5d11 33 fields · synced May 31, 2026