Identity
- Trade Name
- Optetrak Logic FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Model / Reference
- 02-012-48-6013 FDA UDI
Identifiers
- Catalog Number
- 02-012-48-6013 FDA UDI
- Primary DI / UDI-DI
- 10885862174703 FDA UDI
- 510(k) Number
- K121307 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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 — 13 Millimeter FDA UDI
Category: Tibial insert
Optetrak Logic by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121307 also covers:
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, Inc.
- Optetrak Logic — Exactech, 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
- Exactech, Inc.
Sources (1)
- FDA UDI b472233c-6e89-407a-84d0-9ad9b4660733 35 fields · synced Jun 8, 2026