The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Titanium Cannulated Tibial Nail (ti Ctn).
| Device ID | K962047 |
| 510k Number | K962047 |
| Device Name: | TITANIUM CANNULATED TIBIAL NAIL (TI CTN) |
| Classification | Nail, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Angela Silvestri |
| Correspondent | Angela Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679485336S0 | K962047 | 000 |
| H67945948S0 | K962047 | 000 |
| H67945946S0 | K962047 | 000 |
| H67945944S0 | K962047 | 000 |
| H67945942S0 | K962047 | 000 |
| H67945940S0 | K962047 | 000 |
| H67945938S0 | K962047 | 000 |
| H67945936S0 | K962047 | 000 |
| H67945934S0 | K962047 | 000 |
| H67945932S0 | K962047 | 000 |
| H67945930S0 | K962047 | 000 |
| H67945928S0 | K962047 | 000 |
| H67945926S0 | K962047 | 000 |
| H679459100S0 | K962047 | 000 |
| H6794581200 | K962047 | 000 |
| H67945950S0 | K962047 | 000 |
| H67945952S0 | K962047 | 000 |
| H679485327S0 | K962047 | 000 |
| H679458110S0 | K962047 | 000 |
| H67945995S0 | K962047 | 000 |
| H67945990S0 | K962047 | 000 |
| H67945985S0 | K962047 | 000 |
| H67945980S0 | K962047 | 000 |
| H67945976S0 | K962047 | 000 |
| H67945972S0 | K962047 | 000 |
| H67945968S0 | K962047 | 000 |
| H67945964S0 | K962047 | 000 |
| H67945960S0 | K962047 | 000 |
| H67945958S0 | K962047 | 000 |
| H67945956S0 | K962047 | 000 |
| H67945954S0 | K962047 | 000 |
| H679458110 | K962047 | 000 |