I.T.S. Hand Locking Plates System - HLS
FDA 510(k) clearance K142418 · decided 2014-09-26
Clearance details
- K-number
- K142418
- Device name
- I.T.S. Hand Locking Plates System - HLS
- Applicant
- I.T.S. GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-08-28
- Decision date
- 2014-09-26
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lassinitzhoehe/Graz, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HLS - Hand Locking Plates System with the below descriptions and corresponding article num recall (Z-1607-2026) | I.T.S. GmbH | 2026-03-20 |