The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Knee Compression Hook System.
Device ID | K790465 |
510k Number | K790465 |
Device Name: | KNEE COMPRESSION HOOK SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-05 |
Decision Date | 1979-04-12 |