The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Corstren Compression Tube & Plate.
Device ID | K830196 |
510k Number | K830196 |
Device Name: | CORSTREN COMPRESSION TUBE & PLATE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-20 |
Decision Date | 1983-03-25 |