The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/dn Intramedullary Fixation System.
Device ID | K142281 |
510k Number | K142281 |
Device Name: | ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Patrick Mccullagh |
Correspondent | Stephen H. Mckelvey 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 | 2014-08-15 |
Decision Date | 2014-10-22 |
Summary: | summary |