DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
FDA 510(k) clearance K053536 · decided 2006-03-16
Clearance details
- K-number
- K053536
- Device name
- DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-12-19
- Decision date
- 2006-03-16
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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