The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Aim Supracondylar Nail.
| Device ID | K934962 |
| 510k Number | K934962 |
| Device Name: | AIM SUPRACONDYLAR NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Claude Pering |
| Correspondent | Claude Pering ACE ORTHOPEDIC MANUFACTURING 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 | 1993-10-18 |
| Decision Date | 1994-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868005336 | K934962 | 000 |
| 00887868005329 | K934962 | 000 |
| 00887868005312 | K934962 | 000 |
| 00887868005305 | K934962 | 000 |
| 00887868005299 | K934962 | 000 |
| 00887868005282 | K934962 | 000 |
| 00887868000874 | K934962 | 000 |