THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
FDA 510(k) clearance K022377 · decided 2002-12-10
Clearance details
- K-number
- K022377
- Device name
- THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-22
- Decision date
- 2002-12-10
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- KWT
- Device class
- 2
- Regulation number
- 888.3650
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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