The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Zimmer Dto Implant.
Device ID | K071879 |
510k Number | K071879 |
Device Name: | ZIMMER DTO IMPLANT |
Classification | Posterior Metal/polymer Spinal System, Fusion |
Applicant | ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55441 |
Contact | Nicole Bowden |
Correspondent | Nicole Bowden ZIMMER SPINE, INC 7375 Blush Lake Rd Minneapolis, MN 55441 |
Product Code | NQP |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-09 |
Decision Date | 2007-10-05 |
Summary: | summary |