The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Tm Ardis Interbody System Tm Ardis Interbody System Instrumenation.
| Device ID | K113561 |
| 510k Number | K113561 |
| Device Name: | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Judith Rosen |
| Correspondent | Judith Rosen ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-05-29 |
| Summary: | summary |