The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Periarticular Plating System.
Device ID | K142579 |
510k Number | K142579 |
Device Name: | Zimmer Periarticular Plating System |
Classification | Plate, Fixation, Bone |
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 | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-15 |
Decision Date | 2014-10-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024052314 | K142579 | 000 |
00889024052505 | K142579 | 000 |
00889024052192 | K142579 | 000 |
00889024052185 | K142579 | 000 |
00889024052178 | K142579 | 000 |
00889024052161 | K142579 | 000 |
00889024052154 | K142579 | 000 |
00889024052147 | K142579 | 000 |
00889024052130 | K142579 | 000 |
00889024052208 | K142579 | 000 |
00889024052215 | K142579 | 000 |
00889024052222 | K142579 | 000 |
00889024052307 | K142579 | 000 |
00889024052291 | K142579 | 000 |
00889024052284 | K142579 | 000 |
00889024052277 | K142579 | 000 |
00889024052260 | K142579 | 000 |
00889024052253 | K142579 | 000 |
00889024052246 | K142579 | 000 |
00889024052239 | K142579 | 000 |
00889024052123 | K142579 | 000 |