THE ICR KNEE
FDA 510(k) clearance K820719 · decided 1982-05-12
Clearance details
- K-number
- K820719
- Device name
- THE ICR KNEE
- Applicant
- American Ortomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-16
- Decision date
- 1982-05-12
- Days to decision
- 57 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.