The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Tm Ardis Interbody System Inserter.
Device ID | K123602 |
510k Number | K123602 |
Device Name: | TM ARDIS INTERBODY SYSTEM INSERTER |
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 | 2012-11-21 |
Decision Date | 2013-03-01 |
Summary: | summary |