Identity
- Trade Name
- Optetrak Unicondylar FDA UDI
- Generic Name
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
- Model / Reference
- 252-23-01 FDA UDI
Identifiers
- Catalog Number
- 252-23-01 FDA UDI
- Primary DI / UDI-DI
- 10885862065933 FDA UDI
- 510(k) Number
- K040889 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDI
Category: Uncoated unicondylar knee tibia prosthesis, polyethylene
Optetrak Unicondylar by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated unicondylar knee tibia prosthesis, polyethylene.
- JOURNEY — Smith & Nephew, Inc. · Class II
- SIGMA — DEPUY (IRELAND) · Class II
- RESTORIS — MAKO Surgical Corp. · Class II
- HLS Uni Evolution — CORIN LTD · Class II
- ZUK — Smith & Nephew, Inc. · Class II
- ZUK — Smith & Nephew, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K040889 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
- Exactech, Inc.
Sources (1)
- FDA UDI 3bb962e0-556a-4132-a601-bcd145b0ca25 35 fields · synced Jun 1, 2026