The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cervifix/ Axon.
| Device ID | K023675 |
| 510k Number | K023675 |
| Device Name: | SYNTHES CERVIFIX/ AXON |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2002-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814989140 | K023675 | 000 |
| H981042006660 | K023675 | 000 |
| H981042006650 | K023675 | 000 |
| H981042006640 | K023675 | 000 |
| H981042006250 | K023675 | 000 |
| H981042006240 | K023675 | 000 |
| H981042006230 | K023675 | 000 |
| H981042006220 | K023675 | 000 |
| H981042006210 | K023675 | 000 |
| H981042006200 | K023675 | 000 |
| H981042006190 | K023675 | 000 |
| H981042006180 | K023675 | 000 |
| H981042006170 | K023675 | 000 |
| H981042006160 | K023675 | 000 |
| H981042006150 | K023675 | 000 |
| H981042006670 | K023675 | 000 |
| H981042006680 | K023675 | 000 |
| H981042006690 | K023675 | 000 |
| H9814054930 | K023675 | 000 |
| H9814054920 | K023675 | 000 |
| H9814054910 | K023675 | 000 |
| H9814054900 | K023675 | 000 |
| H9814054890 | K023675 | 000 |
| H9814054880 | K023675 | 000 |
| H9814054870 | K023675 | 000 |
| H9814054860 | K023675 | 000 |
| H981042006750 | K023675 | 000 |
| H981042006740 | K023675 | 000 |
| H981042006730 | K023675 | 000 |
| H981042006720 | K023675 | 000 |
| H981042006710 | K023675 | 000 |
| H981042006700 | K023675 | 000 |
| H981042006140 | K023675 | 000 |