The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for Ardis Spacer.
| Device ID | K073202 |
| 510k Number | K073202 |
| Device Name: | ARDIS SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG F Austin, TX 78727 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG F Austin, TX 78727 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2008-01-30 |
| Summary: | summary |