Optical 20-8000-010-59
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024304741 | Date7 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110054 | Date24 Mar 2011 | StatusActive |
Official records
- AccessGUDID record 00889024304741
- FDA 510(k) database K110054
Recalls
-
- Ongoing Z-0721-2022
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
-
- Terminated Z-1881-2017
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optical
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- 20-8000-010-59
- Primary DI / UDI-DI
- 00889024304741
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Orthosoft Inc
Properties
Other properties (12)
- Supplied sterile: No
- Single use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No