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 |