AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM
FDA 510(k) clearance K922734 · decided 1992-09-10
Clearance details
- K-number
- K922734
- Device name
- AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM
- Applicant
- Orthomet, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1992-06-08
- Decision date
- 1992-09-10
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.