ORTHO SOLUTIONS ULTOS PLATING SYSTEM
FDA 510(k) clearance K141784 · decided 2014-07-23
Clearance details
- K-number
- K141784
- Device name
- ORTHO SOLUTIONS ULTOS PLATING SYSTEM
- Applicant
- Ortho Solutions Limited
- Decision
- Substantially Equivalent
- Date received
- 2014-07-02
- Decision date
- 2014-07-23
- Days to decision
- 21 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 |
|---|---|---|
| Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, recall (Z-0230-2026) | CPM Medical Consultants, LLC. | 2025-10-21 |
| Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West recall (Z-0026-2016) | Ortho Solutions Inc | 2015-10-06 |