MECRON UNCEMENTED STRUCTURED STEM HIP
FDA 510(k) clearance K854191 · decided 1985-11-13
Clearance details
- K-number
- K854191
- Device name
- MECRON UNCEMENTED STRUCTURED STEM HIP
- Applicant
- Mecron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-12
- Decision date
- 1985-11-13
- Days to decision
- 93 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.