MOST OPTIONS SYSTEM
FDA 510(k) clearance K013031 · decided 2001-12-07
Clearance details
- K-number
- K013031
- Device name
- MOST OPTIONS SYSTEM
- Applicant
- Sulzer Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-10
- Decision date
- 2001-12-07
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KRO
- Device class
- 2
- Regulation number
- 888.3510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB recall (Z-1250-2014) | Zimmer, Inc. | 2014-03-20 |
| Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF recall (Z-0996-2009) | Zimmer Inc. | 2009-03-09 |
| MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distrib recall (Z-0539-05) | Zimmer Austin, Inc | 2005-02-15 |