The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Lps-flex Prolong Highly Crosslinked Polyethylene Articular Surfaces.
Device ID | K042271 |
510k Number | K042271 |
Device Name: | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Brandon Hipsher |
Correspondent | Brandon Hipsher ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-23 |
Decision Date | 2004-10-13 |
Summary: | summary |