The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Periarticular Locking System.
Device ID | K141734 |
510k Number | K141734 |
Device Name: | ZIMMER PERIARTICULAR LOCKING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Stephen H Mckelvey, Ma,rac |
Correspondent | Stephen H Mckelvey, Ma,rac ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-27 |
Decision Date | 2014-08-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024060470 | K141734 | 000 |
00889024060661 | K141734 | 000 |
00889024060692 | K141734 | 000 |
00889024060708 | K141734 | 000 |
00889024060753 | K141734 | 000 |
00889024060760 | K141734 | 000 |
00889024060777 | K141734 | 000 |
00889024060784 | K141734 | 000 |
00889024060791 | K141734 | 000 |
00889024060654 | K141734 | 000 |
00889024060647 | K141734 | 000 |
00889024060487 | K141734 | 000 |
00889024060555 | K141734 | 000 |
00889024060562 | K141734 | 000 |
00889024060593 | K141734 | 000 |
00889024060609 | K141734 | 000 |
00889024060616 | K141734 | 000 |
00889024060623 | K141734 | 000 |
00889024060630 | K141734 | 000 |
00889024060807 | K141734 | 000 |
00889024060814 | K141734 | 000 |
00889024060821 | K141734 | 000 |
00889024060944 | K141734 | 000 |
00889024060951 | K141734 | 000 |
00889024060968 | K141734 | 000 |
00889024060975 | K141734 | 000 |
00889024060982 | K141734 | 000 |
00889024060531 | K141734 | 000 |
00889024060548 | K141734 | 000 |
00889024060678 | K141734 | 000 |
00889024060937 | K141734 | 000 |
00889024060913 | K141734 | 000 |
00889024060838 | K141734 | 000 |
00889024060845 | K141734 | 000 |
00889024060852 | K141734 | 000 |
00889024060869 | K141734 | 000 |
00889024060876 | K141734 | 000 |
00889024060883 | K141734 | 000 |
00889024060890 | K141734 | 000 |
00889024060906 | K141734 | 000 |
00889024060920 | K141734 | 000 |