SHOULDER FIXATION SYSTEM
FDA 510(k) clearance K060290 · decided 2006-02-27
Clearance details
- K-number
- K060290
- Device name
- SHOULDER FIXATION SYSTEM
- Applicant
- Hand Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-02-06
- Decision date
- 2006-02-27
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LXT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.