The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Modificaton To: Zimmer Periarticular Locking Plates And Screws.
Device ID | K070906 |
510k Number | K070906 |
Device Name: | MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Mason W Robbins |
Correspondent | Mason W Robbins ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-02 |
Decision Date | 2007-05-01 |
Summary: | summary |