TOTAL AND HEMI SHOULDER SYSTEM
FDA 510(k) clearance K060988 · decided 2006-12-06
Clearance details
- K-number
- K060988
- Device name
- TOTAL AND HEMI SHOULDER SYSTEM
- Applicant
- Dvo Extremity Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-04-10
- Decision date
- 2006-12-06
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Derby, CT, US
- Third-party review
- No
- Expedited review
- No
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