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 |