The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Interlocking Intramedullary Nails.
| Device ID | K884610 |
| 510k Number | K884610 |
| Device Name: | INTERLOCKING INTRAMEDULLARY NAILS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Barry R Sisson |
| Correspondent | Barry R Sisson DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1988-12-01 |