TEMA Elbow system - Line extension
FDA 510(k) clearance K222807 · decided 2022-10-26
Clearance details
- K-number
- K222807
- Device name
- TEMA Elbow system - Line extension
- Applicant
- Lima Corporate S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-16
- Decision date
- 2022-10-26
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JDB
- Device class
- 2
- Regulation number
- 888.3160
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Villanova Di San Daniele Del Friuli, IT
- Third-party review
- No
- Expedited review
- No
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| LATITUDE ELBOW PROTHESIS (K070787) | Tornier | 2007-08-24 |
| SBI LATERAL RADIO CAPITELLUM (K070236) | Small Bone Innovations, Inc. | 2007-02-21 |
| RHS (K060438) | Tornier | 2006-04-18 |
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| TORNIER ELBOW PROSTHESIS (K050848) | Tornier | 2005-07-14 |
| MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218) | Tornier | 2003-05-16 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow recall (Z-0744-2025) | Limacorporate S.p.A | 2024-12-20 |