20-8000-000-32
20-8000-000-32 is a Class II device made by Orthosoft Inc, cleared under FDA 510(k) K110054 on 24 Mar 2011 and listed in FDA GUDID since 12 Sep 2017 (UDI-DI 00889024492745), active as of 22 Oct 2026. 2 FDA recalls are 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 | Number00889024492745 | Date12 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110054 | Date24 Mar 2011 | StatusActive |
Official records
- AccessGUDID record 00889024492745
- FDA 510(k) database K110054
Across registries
- FDA 510(k) K110054 decided 24 Mar 2011 Active
- FDA GUDID UDI-DI 00889024492745 listed 12 Sep 2017 Listed
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.
Timeline
- Cleared FDA 510(k) K110054
- Recall initiated FDA recalls Z-1881-2017
- Listed FDA GUDID 00889024492745
- Recall initiated FDA recalls Z-0721-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic bone pin, non-bioabsorbable
- Model / reference
- 20-8000-000-32
- Primary DI / UDI-DI
- 00889024492745
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic bone pin, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 80 MillimeterOuter Diameter — 3.2 Millimeter