Identity
- Trade Name
- ENDCAP, TIBIAL NAIL FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- 8001-01-000 FDA UDI
Identifiers
- Catalog Number
- 800101000 FDA UDI
- Primary DI / UDI-DI
- 00887868031335 FDA UDI
- 510(k) Number
- K970202 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail end-cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Category: Bone nail end-cap
Endcap, Tibial Nail by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone nail end-cap.
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- Micro Screws (INOX) — devemed GmbH · Class IIb
Cleared under the same submission
K970202 also covers:
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 63166c82-5972-4aac-ae72-9ae458403e2d 35 fields · synced May 30, 2026