The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Universal Spinal Hook, Rod, Pedicle/sacral Screw Fixation System.
Device ID | K980928 |
510k Number | K980928 |
Device Name: | SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
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 | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-11 |
Decision Date | 1998-05-11 |
Summary: | summary |