The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Op Spine System.
| Device ID | K120291 |
| 510k Number | K120291 |
| Device Name: | OP SPINE SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Applicant | ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw, IN 46582 |
| Contact | Mark Fox |
| Correspondent | Mark Fox ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw, IN 46582 |
| Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-31 |
| Decision Date | 2012-04-16 |
| Summary: | summary |