HLS UNI EVOLUTION PROSTHESIS
FDA 510(k) clearance K022211 · decided 2003-05-22
Clearance details
- K-number
- K022211
- Device name
- HLS UNI EVOLUTION PROSTHESIS
- Applicant
- Tornier
- Decision
- Substantially Equivalent
- Date received
- 2002-07-08
- Decision date
- 2003-05-22
- Days to decision
- 318 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montbonnot, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.