I.T.S. EXTREMITY FIXATION SYSTEMS
FDA 510(k) clearance K131722 · decided 2013-08-07
Clearance details
- K-number
- K131722
- Device name
- I.T.S. EXTREMITY FIXATION SYSTEMS
- Applicant
- I.T.S. GmbH
- Decision
- Substantially Equivalent
- Date received
- 2013-06-12
- Decision date
- 2013-08-07
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HRS
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below d recall (Z-1605-2026) | I.T.S. GmbH | 2026-03-20 |
| HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article N recall (Z-1606-2026) | I.T.S. GmbH | 2026-03-20 |