The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Continuum Acetabular System, Zimmer Trilogy It Acetabular System.
Device ID | K091508 |
510k Number | K091508 |
Device Name: | ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Benjamin C Curson |
Correspondent | Benjamin C Curson ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | LPH |
Subsequent Product Code | JDI |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-22 |
Decision Date | 2009-09-11 |
Summary: | summary |