ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
FDA 510(k) clearance K111086 · decided 2011-06-17
Clearance details
- K-number
- K111086
- Device name
- ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
- Applicant
- OrthoPediatrics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-19
- Decision date
- 2011-06-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2 recall (Z-2796-2015) | OrthoPediatrics Corp | 2015-09-18 |