The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Legacy Posterior Stabilized (lps); Lps-flex Fixed Bearing Femoral And Articular Surface Co.
Device ID | K991581 |
510k Number | K991581 |
Device Name: | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Stephen Mckelvey |
Correspondent | Stephen Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-07 |
Decision Date | 1999-07-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024209275 | K991581 | 000 |