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 |