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 |