OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
FDA 510(k) clearance K894124 · decided 1989-09-11
Clearance details
- K-number
- K894124
- Device name
- OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1989-06-12
- Decision date
- 1989-09-11
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both t recall (Z-0483-2014) | Stryker Howmedica Osteonics Corp. | 2013-12-11 |
| Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous recall (Z-0387-2013) | Stryker Howmedica Osteonics Corp. | 2012-11-19 |
| Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous recall (Z-0388-2013) | Stryker Howmedica Osteonics Corp. | 2012-11-19 |
| 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteon recall (Z-2007-2008) | Stryker Howmedica Osteonics Corp. | 2008-09-22 |