SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
FDA 510(k) clearance K032108 · decided 2004-01-15
Clearance details
- K-number
- K032108
- Device name
- SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-08
- Decision date
- 2004-01-15
- Days to decision
- 191 days
- Clearance type
- Abbreviated
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.