The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Threaded Pins.
Device ID | K920188 |
510k Number | K920188 |
Device Name: | THREADED PINS |
Classification | Fastener, Fixation, Biodegradable, Hard Tissue |
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 | MBJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-15 |
Decision Date | 1993-05-12 |