510(k) K051590 ยท HSB Rod, Fixation, Intramedullary And Accessories
T2 ANKLE ARTHRODESIS NAIL
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jul 29, 2005 |
| Received | Jun 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2018 | Stryker GmbH Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S
T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S
T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S
T2 LONG PROXIMAL HUM Terminated |
HSB | None listed |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; Catalog number 18181030S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Int Terminated |
HSB | None listed |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog Number: 18181130S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Inte Terminated |
HSB | None listed |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog number: 18181230S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Int Terminated |
HSB | None listed |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
In Terminated |
HSB | None listed |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
In Terminated |
HSB | None listed |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog number: 18191230S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Int Terminated |
HSB | None listed |
| Aug 18, 2009 | Stryker Howmedica Osteonics Corp. T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics
The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.