510(k) K032244 ยท HSB Rod, Fixation, Intramedullary And Accessories
GAMMA 3 NAIL SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 8, 2003 |
| Received | Jul 22, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Partially Threaded T2 Tibia 5x55 mm
Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabili Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x30 mm
Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliza Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x35 mm
Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x40 mm
Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x45 mm
Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm
Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker End Cap, Std, Ti Gamma3
Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.