The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Depuy Pulse Anterior Cerical Plate System.
| Device ID | K112724 |
| 510k Number | K112724 |
| Device Name: | DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-19 |
| Decision Date | 2011-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034392400 | K112724 | 000 |
| 10705034392257 | K112724 | 000 |
| 10705034392264 | K112724 | 000 |
| 10705034392271 | K112724 | 000 |
| 10705034392288 | K112724 | 000 |
| 10705034392295 | K112724 | 000 |
| 10705034392301 | K112724 | 000 |
| 10705034392318 | K112724 | 000 |
| 10705034392325 | K112724 | 000 |
| 10705034392332 | K112724 | 000 |
| 10705034392349 | K112724 | 000 |
| 10705034392356 | K112724 | 000 |
| 10705034392363 | K112724 | 000 |
| 10705034392370 | K112724 | 000 |
| 10705034392387 | K112724 | 000 |
| 10705034392394 | K112724 | 000 |
| 10705034392240 | K112724 | 000 |