APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
FDA 510(k) clearance K954800 · decided 1996-04-25
Clearance details
- K-number
- K954800
- Device name
- APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
- Applicant
- Intermedics Orthopedics
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-09-27
- Decision date
- 1996-04-25
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- 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 |
|---|---|---|
| CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally matur recall (Z-1135-2105) | Zimmer Gmbh | 2015-02-20 |