The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Bone Screws.
| Device ID | K082949 |
| 510k Number | K082949 |
| Device Name: | ORTHOPEDIATRICS BONE SCREWS |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-02 |
| Decision Date | 2008-11-25 |
| Summary: | summary |