The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Pediatric Rod System.
| Device ID | K980761 |
| 510k Number | K980761 |
| Device Name: | SYNTHES SPINE PEDIATRIC ROD SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-27 |
| Decision Date | 1998-08-04 |
| Summary: | summary |