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 |