PROFORM HIP SYSTEM
FDA 510(k) clearance K934161 · decided 1994-03-10
Clearance details
- K-number
- K934161
- Device name
- PROFORM HIP SYSTEM
- Applicant
- Stelkast Company
- Decision
- Substantially Equivalent
- Date received
- 1993-08-27
- Decision date
- 1994-03-10
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- JDO
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S002) | Stelkast Company | 2011-04-22 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S001) | Stelkast Company | 2009-05-08 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051) | Stelkast Company | 2006-05-12 |