PSL TOTAL HIP REPLACEMENT SYSTEM
FDA 510(k) clearance K922500 · decided 1994-01-07
Clearance details
- K-number
- K922500
- Device name
- PSL TOTAL HIP REPLACEMENT SYSTEM
- Applicant
- Biopro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-27
- Decision date
- 1994-01-07
- Days to decision
- 590 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Port Huron, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.