FR.O.H. CALCANEUS REPAIR SYSTEM
FDA 510(k) clearance K051642 · decided 2005-08-22
Clearance details
- K-number
- K051642
- Device name
- FR.O.H. CALCANEUS REPAIR SYSTEM
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-06-20
- Decision date
- 2005-08-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- NDF
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Prior Lake, MN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| EBI DYNAFIX VS OSTEOTOMY SYSTEM (K021749) | Ebi, L.P. | 2002-08-12 |
| EBI DYNAFIX VS OSTEOTOMY SYSTEM (K010551) | Ebi, L.P. | 2001-05-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Pl recall (Z-1595-2026) | I.T.S. GmbH | 2026-03-20 |