The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To The Synthes (usa) Universal Spinal Hook, Rod, And And Sacral Screw Fixation System In 316l Stainless Ste.
Device ID | K963357 |
510k Number | K963357 |
Device Name: | MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Diane T Brown |
Correspondent | Diane T Brown SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-26 |
Decision Date | 1997-01-09 |
Summary: | summary |