Identity
- Trade Name
- OPTILOCK FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- 22165 FDA UDI
Identifiers
- Catalog Number
- 22165 FDA UDI
- Primary DI / UDI-DI
- 00888480223825 FDA UDI
- 510(k) Number
- K040908 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Optilock by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K040908 also covers:
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — Biomet Orthopedics, Inc.
- OPTILOCK — 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 8771ae58-7b03-4d2b-a75d-150a96db6b34 36 fields · synced Jun 1, 2026