The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Anterior Cervical Compression System.
| Device ID | K033844 |
| 510k Number | K033844 |
| Device Name: | SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2004-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98141140000 | K033844 | 000 |
| H9814132120 | K033844 | 000 |
| H9814132140 | K033844 | 000 |
| H9814132400 | K033844 | 000 |
| H9814132420 | K033844 | 000 |
| H9814132440 | K033844 | 000 |
| H9814132500 | K033844 | 000 |
| H9814132520 | K033844 | 000 |
| H9814132540 | K033844 | 000 |
| H9814505010 | K033844 | 000 |
| H9814505020 | K033844 | 000 |
| H9814505030 | K033844 | 000 |
| H9814505040 | K033844 | 000 |
| H9814132100 | K033844 | 000 |
| H9814132040 | K033844 | 000 |
| H9814132020 | K033844 | 000 |
| H9814114020 | K033844 | 000 |
| H9814114040 | K033844 | 000 |
| H9814114100 | K033844 | 000 |
| H9814114120 | K033844 | 000 |
| H9814114140 | K033844 | 000 |
| H9814114400 | K033844 | 000 |
| H9814114420 | K033844 | 000 |
| H9814114440 | K033844 | 000 |
| H9814114500 | K033844 | 000 |
| H9814114520 | K033844 | 000 |
| H9814114540 | K033844 | 000 |
| H98141320000 | K033844 | 000 |
| H9814505050 | K033844 | 000 |
| H9814505060 | K033844 | 000 |
| H9814505280 | K033844 | 000 |
| H9814505290 | K033844 | 000 |
| H9814505310 | K033844 | 000 |
| H9814505320 | K033844 | 000 |
| H9814505330 | K033844 | 000 |
| H9814505340 | K033844 | 000 |
| H9814505350 | K033844 | 000 |
| H9814505360 | K033844 | 000 |
| H9814505370 | K033844 | 000 |
| H9814505380 | K033844 | 000 |
| H9814505390 | K033844 | 000 |
| H9814505400 | K033844 | 000 |
| H9814505270 | K033844 | 000 |
| H9814505260 | K033844 | 000 |
| H9814505250 | K033844 | 000 |
| H9814505070 | K033844 | 000 |
| H9814505110 | K033844 | 000 |
| H9814505120 | K033844 | 000 |
| H9814505130 | K033844 | 000 |
| H9814505140 | K033844 | 000 |
| H9814505150 | K033844 | 000 |
| H9814505160 | K033844 | 000 |
| H9814505170 | K033844 | 000 |
| H9814505210 | K033844 | 000 |
| H9814505220 | K033844 | 000 |
| H9814505230 | K033844 | 000 |
| H9814505240 | K033844 | 000 |
| H9814505410 | K033844 | 000 |