KNEE PROSTHESIS
FDA 510(k) clearance K810540 · decided 1981-04-07
Clearance details
- K-number
- K810540
- Device name
- KNEE PROSTHESIS
- Applicant
- Cintor Orthopaedic Div.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-27
- Decision date
- 1981-04-07
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- HRY
- Device class
- 2
- Regulation number
- 888.3530
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.