NOVOHIP TOTAL HIP SYSTEM
FDA 510(k) clearance K132158 · decided 2014-02-21
Clearance details
- K-number
- K132158
- Device name
- NOVOHIP TOTAL HIP SYSTEM
- Applicant
- Novosource, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-12
- Decision date
- 2014-02-21
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Dayton, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip recall (Z-0483-2025) | Novosource, LLC | 2024-11-18 |