The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Intramedullary Nail System.
Device ID | K965098 |
510k Number | K965098 |
Device Name: | INTRAMEDULLARY NAIL SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Karen Cain |
Correspondent | Karen Cain 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 | 1996-12-20 |
Decision Date | 1997-02-28 |
Summary: | summary |