Optetrak Logic 02-012-48-4013
Optetrak Logic 02-012-48-4013 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K111400 on 28 Jul 2011 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862174505), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10885862174505 | Date30 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111400 | Date28 Jul 2011 | StatusActive |
Official records
- AccessGUDID record 10885862174505
- FDA 510(k) database K111400
Across registries
- FDA 510(k) K111400 decided 28 Jul 2011 Active
- FDA GUDID UDI-DI 10885862174505 listed 30 Oct 2015 Listed
Recalls
-
- Ongoing Z-0583-2024
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Timeline
- Cleared FDA 510(k) K111400
- Listed FDA GUDID 10885862174505
- Recall initiated FDA recalls Z-0583-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optetrak Logic
- Generic name
- Tibial insert
- Model / Ref / Catalog
- 02-012-48-4013
- Primary DI / UDI-DI
- 10885862174505
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Tibial insert
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 13 Millimeter