OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
FDA 510(k) clearance K951671 · decided 1995-09-06
Clearance details
- K-number
- K951671
- Device name
- OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-11
- Decision date
- 1995-09-06
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- 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 |
|---|---|---|
| Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics C recall (Z-1677-2012) | Stryker Howmedica Osteonics Corp. | 2012-05-29 |