DISTAL CENTRALIZER, EXETER II HIP SYSTEM
FDA 510(k) clearance K974054 · decided 1997-12-23
Clearance details
- K-number
- K974054
- Device name
- DISTAL CENTRALIZER, EXETER II HIP SYSTEM
- Applicant
- Howmedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-27
- Decision date
- 1997-12-23
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used recall (Z-1601-2010) | Stryker Howmedica Osteonics Corp. | 2010-05-13 |
| Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For recall (Z-1593-2010) | Stryker Howmedica Osteonics Corp. | 2010-05-12 |
| Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. Fo recall (Z-1594-2010) | Stryker Howmedica Osteonics Corp. | 2010-05-12 |