The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Longevity It Highly Crosslinked Polyethyene Liners.
Device ID | K123019 |
510k Number | K123019 |
Device Name: | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | ZIMMER, INC. 1800 WEST CENTER STREET Warsaw, IN 46580 |
Contact | Rebecca Brooks |
Correspondent | Rebecca Brooks ZIMMER, INC. 1800 WEST CENTER STREET Warsaw, IN 46580 |
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 | 2012-09-28 |
Decision Date | 2012-10-22 |
Summary: | summary |