COMPREHENSIVE HUMERAL FRACTURE SYSTEM
FDA 510(k) clearance K023063 · decided 2002-12-13
Clearance details
- K-number
- K023063
- Device name
- COMPREHENSIVE HUMERAL FRACTURE SYSTEM
- Applicant
- Biomet Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-16
- Decision date
- 2002-12-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KWT
- Device class
- 2
- Regulation number
- 888.3650
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation R recall (Z-3289-2011) | Biomet, Inc. | 2011-09-30 |