The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ace Aim Ttc Fusion Nail.
| Device ID | K003797 |
| 510k Number | K003797 |
| Device Name: | ACE AIM TTC FUSION NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2000-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868004803 | K003797 | 000 |
| 00887868004810 | K003797 | 000 |
| 00887868032950 | K003797 | 000 |
| 00887868032943 | K003797 | 000 |
| 00887868032936 | K003797 | 000 |
| 00887868032929 | K003797 | 000 |
| 00887868032912 | K003797 | 000 |
| 00887868032905 | K003797 | 000 |
| 00887868032967 | K003797 | 000 |
| 00887868033001 | K003797 | 000 |
| 00887868032998 | K003797 | 000 |
| 00887868032981 | K003797 | 000 |
| 00887868009839 | K003797 | 000 |
| 00887868009846 | K003797 | 000 |
| 00887868009853 | K003797 | 000 |
| 00887868004797 | K003797 | 000 |
| 00887868034077 | K003797 | 000 |
| 00887868034060 | K003797 | 000 |
| 00887868034053 | K003797 | 000 |
| 00887868034046 | K003797 | 000 |
| 00887868034039 | K003797 | 000 |
| 00887868034022 | K003797 | 000 |
| 00887868034015 | K003797 | 000 |
| 00887868034008 | K003797 | 000 |
| 00887868009877 | K003797 | 000 |
| 00887868009860 | K003797 | 000 |
| 00887868032974 | K003797 | 000 |