The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Continuum And Trilogy Integrated Taper (it) Acetabular Systems.
Device ID | K151448 |
510k Number | K151448 |
Device Name: | Continuum And Trilogy Integrated Taper (IT) Acetabular Systems |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 |
Contact | Keith Proctor |
Correspondent | Paul Hardy ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 |
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 | 2015-05-29 |
Decision Date | 2015-08-13 |
Summary: | summary |