The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Mcaffee Universal Spinal System (muss).
Device ID | K901507 |
510k Number | K901507 |
Device Name: | MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS) |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
Contact | Sam Son |
Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-30 |
Decision Date | 1992-01-28 |