510(k) K955599 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Feb 22, 1996 |
| Received | Dec 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone c Terminated |
GDY | None listed |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile, Stryker Instruments Kalamazoo, MI.
The femoral sponge is an absorbent that is used to d Terminated |
GDY | None listed |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10, Stryker Instruments, Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary can Terminated |
GDY | None listed |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instruments, Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary canal prior t Terminated |
GDY | None listed |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the app Terminated |
GDY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.