SMR REVERSE SHOULDER SYSTEM
FDA 510(k) clearance K110598 · decided 2011-08-18
Clearance details
- K-number
- K110598
- Device name
- SMR REVERSE SHOULDER SYSTEM
- Applicant
- Lima Corporate S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-02
- Decision date
- 2011-08-18
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Winona Lake, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.