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; Longevity It Highly Crosslinked Polyethylene Elevated Li.
Device ID | K103662 |
510k Number | K103662 |
Device Name: | CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Rebecca Brooks |
Correspondent | Rebecca Brooks 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-15 |
Decision Date | 2011-04-15 |
Summary: | summary |