The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Trabecular Metal (tm) Vertebral Body Replacement (vbr) System Instrument Set.
Device ID | K093127 |
510k Number | K093127 |
Device Name: | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
Contact | Kathleen Rutherford |
Correspondent | Kathleen Rutherford ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-02 |
Decision Date | 2010-03-04 |
Summary: | summary |