Identity
- Trade Name
- OPTILOCK PERIARTICULAR PLATING SYSTEM FDA UDI
- Generic Name
- Knee femur stem prosthesis FDA UDI
- Model / Reference
- 27232 FDA UDI
Identifiers
- Catalog Number
- 27232 FDA UDI
- Primary DI / UDI-DI
- 00880304487857 FDA UDI
- 510(k) Number
- K061098 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Knee femur stem prosthesis 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: Knee femur stem prosthesis
Optilock Periarticular Plating System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur stem prosthesis.
- Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
- Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
- Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- Triathlon — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
K061098 also covers:
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc.
- OPTILOCK PERIARTICULAR PLATING SYSTEM — 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 75a7e9ff-57ff-4d23-8273-6ec7ffd586e5 36 fields · synced May 31, 2026