The following data is part of a premarket notification filed by Depuy Ace Medical Co. with the FDA for Depuy Ace Aim Titanium Tibial Nail.
| Device ID | K970202 |
| 510k Number | K970202 |
| Device Name: | DEPUY ACE AIM TITANIUM TIBIAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Contact | Paul Doner |
| Correspondent | Paul Doner DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868009822 | K970202 | 000 |
| 00887868031335 | K970202 | 000 |