The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Depuy Spine Lateral System.
| Device ID | K090899 |
| 510k Number | K090899 |
| Device Name: | DEPUY SPINE LATERAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene DEPUY SPINE, INC. 325 PARAMOUNT DR. 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 | 2009-04-01 |
| Decision Date | 2009-05-19 |
| Summary: | summary |