The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Depuy Pulse Lumbar Cage System.
| Device ID | K120966 |
| 510k Number | K120966 |
| Device Name: | DEPUY PULSE LUMBAR CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Robin Dinardo |
| Correspondent | Robin Dinardo MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-30 |
| Decision Date | 2012-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034392813 | K120966 | 000 |
| 10705034392684 | K120966 | 000 |
| 10705034392677 | K120966 | 000 |
| 10705034392653 | K120966 | 000 |
| 10705034392646 | K120966 | 000 |
| 10705034392639 | K120966 | 000 |
| 10705034392622 | K120966 | 000 |
| 10705034392615 | K120966 | 000 |
| 10705034392608 | K120966 | 000 |
| 10705034392691 | K120966 | 000 |
| 10705034392707 | K120966 | 000 |
| 10705034392714 | K120966 | 000 |
| 10705034392806 | K120966 | 000 |
| 10705034392790 | K120966 | 000 |
| 10705034392783 | K120966 | 000 |
| 10705034392776 | K120966 | 000 |
| 10705034392769 | K120966 | 000 |
| 10705034392752 | K120966 | 000 |
| 10705034392738 | K120966 | 000 |
| 10705034392721 | K120966 | 000 |
| 10705034392592 | K120966 | 000 |