The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Depuy Pulse Anterior Cervical In-line Plate System.
| Device ID | K123167 |
| 510k Number | K123167 |
| Device Name: | DEPUY PULSE ANTERIOR CERVICAL IN-LINE 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 | 2012-10-09 |
| Decision Date | 2012-12-28 |
| Summary: | summary |