The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Anterior Tension Band (atb) System.
| Device ID | K022791 |
| 510k Number | K022791 |
| Device Name: | SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Vikki M Hoffman |
| Correspondent | Vikki M Hoffman SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-22 |
| Decision Date | 2002-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814967790 | K022791 | 000 |
| H9814891400 | K022791 | 000 |