Identity
- Trade Name
- OPTILOCK VL DISTAL RADIUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- 14-400705 FDA UDI
Identifiers
- Catalog Number
- 14-400705 FDA UDI
- Primary DI / UDI-DI
- 00887868090745 FDA UDI
- 510(k) Number
- K093761 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
Category: Orthopaedic fixation plate, non-bioabsorbable
Optilock Vl Distal Radius by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K093761 also covers:
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
- OPTILOCK VL DISTAL RADIUS — Biomet Orthopedics, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 937535f2-6687-4be1-aa93-e410df7ef18c 36 fields · synced Jun 6, 2026