The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Unreamed Humeral Nail (urhn).
| Device ID | K933518 |
| 510k Number | K933518 |
| Device Name: | SYNTHES UNREAMED HUMERAL NAIL (URHN) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Diane Cochet-wynant |
| Correspondent | Diane Cochet-wynant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1994-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679462965S0 | K933518 | 000 |
| H67945828S0 | K933518 | 000 |
| H679458300 | K933518 | 000 |
| H67945830S0 | K933518 | 000 |
| H679458320 | K933518 | 000 |
| H67945832S0 | K933518 | 000 |
| H679458340 | K933518 | 000 |
| H67945834S0 | K933518 | 000 |
| H67945836S0 | K933518 | 000 |
| H67945838S0 | K933518 | 000 |
| H679458280 | K933518 | 000 |
| H67945826S0 | K933518 | 000 |
| H679458260 | K933518 | 000 |
| H679458360 | K933518 | 000 |
| H679458380 | K933518 | 000 |
| H679458400 | K933518 | 000 |
| H679458440 | K933518 | 000 |
| H679458480 | K933518 | 000 |
| H679458180 | K933518 | 000 |
| H679458200 | K933518 | 000 |
| H679458220 | K933518 | 000 |
| H679458240 | K933518 | 000 |
| H67945840S0 | K933518 | 000 |
| H679458420 | K933518 | 000 |
| H67945842S0 | K933518 | 000 |
| H679458580 | K933518 | 000 |
| H67945858S0 | K933518 | 000 |
| H679458600 | K933518 | 000 |
| H67945860S0 | K933518 | 000 |
| H679458620 | K933518 | 000 |
| H679458640 | K933518 | 000 |
| H6794629500 | K933518 | 000 |
| H6794629550 | K933518 | 000 |
| H6794629600 | K933518 | 000 |
| H67945856S0 | K933518 | 000 |
| H679458560 | K933518 | 000 |
| H67945854S0 | K933518 | 000 |
| H67945844S0 | K933518 | 000 |
| H679458460 | K933518 | 000 |
| H67945846S0 | K933518 | 000 |
| H67945848S0 | K933518 | 000 |
| H679458500 | K933518 | 000 |
| H67945850S0 | K933518 | 000 |
| H679458520 | K933518 | 000 |
| H67945852S0 | K933518 | 000 |
| H679458540 | K933518 | 000 |
| H6794629650 | K933518 | 000 |