510(k) K003018 ยท HSB Rod, Fixation, Intramedullary And Accessories
TITAN TIBIAL NAIL
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 15, 2000 |
| Received | Sep 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2020 | Stryker GmbH Stryker Compression Screw, Advanced T2 Tibia
Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bon Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker End Cap T2 Tibia +10 mm
Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. Terminated |
HSB | None listed |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm
Catalog Number: 18964032S - 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 5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030S Terminated |
HSB | None listed |
| Apr 27, 2018 | Stryker GmbH Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130S Terminated |
HSB | None listed |
| Nov 16, 2007 | Stryker Howmedica Osteonics Corp. Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24232 Schonkirchen, Germany
Distributed in the United States by Howmedica Osteonic Terminated |
None listed | |
| Oct 15, 2003 | Stryker Howmedica Osteonics T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.