METHA HIP SYSTEM
FDA 510(k) clearance K071916 · decided 2008-06-02
Clearance details
- K-number
- K071916
- Device name
- METHA HIP SYSTEM
- Applicant
- Aesculap Implant Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-11
- Decision date
- 2008-06-02
- Days to decision
- 327 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha M recall (Z-3014-2011) | Aesculap Inc | 2011-08-12 |