510(k) K894124 ยท HWC Screw, Fixation, Bone
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Sep 11, 1989 |
| Received | Jun 12, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw
Howmedica Osteonics Corp.
Stryker France
Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm l Terminated |
HWC | None listed |
| Nov 19, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics
Torx 6.5mm
Cancellous Bone Screw
Ref 2030-6525-1
The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. Th Terminated |
HWC | None listed |
| Nov 19, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics
Torx 6.5mm
Cancellous Bone Screw
Ref 2030-6535-1
The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. Th Terminated |
HWC | None listed |
| Sep 22, 2008 | Stryker Howmedica Osteonics Corp. 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Numb Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.