The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Pediplates System.
| Device ID | K081407 |
| 510k Number | K081407 |
| Device Name: | ORTHOPEDIATRICS PEDIPLATES SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw, IN 46580 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw, IN 46580 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | OBT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2008-07-22 |
| Summary: | summary |