DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
FDA 510(k) clearance K130008 · decided 2013-06-25
Clearance details
- K-number
- K130008
- Device name
- DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
- Applicant
- I.T.S. GmbH
- Decision
- Substantially Equivalent
- Date received
- 2013-01-02
- Decision date
- 2013-06-25
- Days to decision
- 174 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 |
|---|---|---|
| I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the b recall (Z-1604-2026) | I.T.S. GmbH | 2026-03-20 |