The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Aim Tibial Nail.
Device ID | K911554 |
510k Number | K911554 |
Device Name: | AIM TIBIAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
Contact | Gloria Teske |
Correspondent | Gloria Teske ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-09 |
Decision Date | 1991-07-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887868000478 | K911554 | 000 |
00887868009822 | K911554 | 000 |