The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Trinica Anterior Lumbar Plate System.
Device ID | K061353 |
510k Number | K061353 |
Device Name: | TRINICA ANTERIOR LUMBAR PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
Contact | Tim Crabtree |
Correspondent | Tim Crabtree ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-15 |
Decision Date | 2006-08-30 |
Summary: | summary |