The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.)universal Spinal Parellel Connector The Universal Spinal Rod And Screw Fixation System.
Device ID | K964416 |
510k Number | K964416 |
Device Name: | SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
Contact | Diane T Brown |
Correspondent | Diane T Brown SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-04 |
Decision Date | 1997-03-17 |
Summary: | summary |