METASUL TAPER LINERS, METASUL FEMORAL HEADS
FDA 510(k) clearance K091973 · decided 2009-11-17
Clearance details
- K-number
- K091973
- Device name
- METASUL TAPER LINERS, METASUL FEMORAL HEADS
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-07-01
- Decision date
- 2009-11-17
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory recall (Z-0850-2016) | Zimmer Biomet, Inc. | 2016-02-22 |
| Metasul Head. Intended for use either with or without bone cement in total hip arthroplast recall (Z-0071-2014) | Zimmer, Inc. | 2013-10-25 |