The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Depuy Pulse Cervical Cage System.
| Device ID | K120517 |
| 510k Number | K120517 |
| Device Name: | DEPUY PULSE CERVICAL CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDOS INTERNATIONAL SARL 325 PARAMOUNT DR Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang MEDOS INTERNATIONAL SARL 325 PARAMOUNT DR Raynham, MA 02767 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034392585 | K120517 | 000 |
| 10705034392486 | K120517 | 000 |
| 10705034392493 | K120517 | 000 |
| 10705034392509 | K120517 | 000 |
| 10705034392516 | K120517 | 000 |
| 10705034392523 | K120517 | 000 |
| 10705034392530 | K120517 | 000 |
| 10705034392547 | K120517 | 000 |
| 10705034392554 | K120517 | 000 |
| 10705034392561 | K120517 | 000 |
| 10705034392578 | K120517 | 000 |
| 10705034392479 | K120517 | 000 |