RESTORATION ACETABULAR WEDGE AUGMENTS
FDA 510(k) clearance K102019 · decided 2011-03-03
Clearance details
- K-number
- K102019
- Device name
- RESTORATION ACETABULAR WEDGE AUGMENTS
- Applicant
- Howmedica Osteonics
- Decision
- Substantially Equivalent
- Date received
- 2010-07-19
- Decision date
- 2011-03-03
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Cor recall (Z-1633-2015) | Stryker Howmedica Osteonics Corp. | 2015-05-19 |