LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
FDA 510(k) clearance K100858 · decided 2010-12-10
Clearance details
- K-number
- K100858
- Device name
- LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
- Applicant
- Lima-Lto S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-26
- Decision date
- 2010-12-10
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- KWT
- Device class
- 2
- Regulation number
- 888.3650
- 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
| Record | Firm | Date |
|---|---|---|
| SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spal recall (Z-2539-2015) | Limacorporate S.p.A | 2015-09-02 |
| SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Tr recall (Z-2540-2015) | Limacorporate S.p.A | 2015-09-02 |