EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
FDA 510(k) clearance K062775 · decided 2007-01-16
Clearance details
- K-number
- K062775
- Device name
- EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
- Applicant
- Ortho Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-18
- Decision date
- 2007-01-16
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, recall (Z-1670-2011) | Ortho Development Corporation | 2011-03-16 |
| Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, D recall (Z-1671-2011) | Ortho Development Corporation | 2011-03-16 |
| Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, D recall (Z-1672-2011) | Ortho Development Corporation | 2011-03-16 |
| Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Developme recall (Z-1673-2011) | Ortho Development Corporation | 2011-03-16 |