KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
FDA 510(k) clearance K922421 · decided 1992-10-15
Clearance details
- K-number
- K922421
- Device name
- KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
- Applicant
- Kinamed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-21
- Decision date
- 1992-10-15
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Newbury Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.