Identity
- Trade Name
- LOCKNUT, CORTICAL FDA UDI
- Generic Name
- Implantable bone nut FDA UDI
- Model / Reference
- 8050-65-000 FDA UDI
Identifiers
- Catalog Number
- 805065000 FDA UDI
- Primary DI / UDI-DI
- 00887868034084 FDA UDI
- 510(k) Number
- K983265 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Implantable bone nut 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
No
FDA UDI
Category: Implantable bone nut
Locknut, Cortical by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone nut.
- HOFFMANN — Stryker Corp. · Class II
- TRUELOK SYSTEM — Orthofix, Inc. · Class II
- Stainless Steel Femoral Retrograde And Ankle Arthrodesis Nailing System — Orthofix, Inc. · Class II
- T2 — Stryker Corp. · Class I
- Nut — I.T.S. GmbH · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- M/DN® — Zimmer, Inc. · Class II
Cleared under the same submission
K983265 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 5823c41f-bab3-46dd-a040-3678952aa05d 36 fields · synced May 30, 2026