The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Marchetti-vicenzi Intramedullary Nail, Humeral.
| Device ID | K972692 |
| 510k Number | K972692 |
| Device Name: | MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Ralph H Larsen |
| Correspondent | Ralph H Larsen ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-17 |
| Decision Date | 1997-09-19 |
| Summary: | summary |