ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
FDA 510(k) clearance K083286 · decided 2009-01-30
Clearance details
- K-number
- K083286
- Device name
- ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
- Applicant
- OrthoPediatrics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-05
- Decision date
- 2009-01-30
- Days to decision
- 86 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 Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plat recall (Z-2843-2016) | OrthoPediatrics Corp | 2016-09-19 |
| 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plat recall (Z-2844-2016) | OrthoPediatrics Corp | 2016-09-19 |
| 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to p recall (Z-1941-2013) | OrthoPediatrics Corp | 2013-08-09 |
| 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy recall (Z-0432-2013) | OrthoPediatrics Corp | 2012-11-22 |
| OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Ho recall (Z-2057-2012) | OrthoPediatrics Corp | 2012-07-20 |