The following data is part of a premarket notification filed by Orthopediatrics, Llc with the FDA for Orthopediatrics Plating System.
| Device ID | K073344 |
| 510k Number | K073344 |
| Device Name: | ORTHOPEDIATRICS PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPEDIATRICS, LLC 210 NORTH BUFFALO STREET Warsaw, IN 46580 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett ORTHOPEDIATRICS, LLC 210 NORTH BUFFALO STREET Warsaw, IN 46580 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-28 |
| Decision Date | 2008-02-19 |
| Summary: | summary |