The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Ardis Interbody System.
| Device ID | K133184 |
| 510k Number | K133184 |
| Device Name: | ARDIS INTERBODY SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55441 |
| Contact | Michelle Lenz |
| Correspondent | Michelle Lenz ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55441 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-01-30 |
| Summary: | summary |