The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Anterior Thoracolumbar Rod Clamp (atrc) System.
Device ID | K974525 |
510k Number | K974525 |
Device Name: | SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
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 | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-02 |
Decision Date | 1998-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H9814982630 | K974525 | 000 |
H9814982620 | K974525 | 000 |
H9814982610 | K974525 | 000 |
H9814890350 | K974525 | 000 |