The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Longevity It Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System And Trilogy Integrated Taper.
| Device ID | K101229 |
| 510k Number | K101229 |
| Device Name: | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024364417 | K101229 | 000 |
| 00889024147898 | K101229 | 000 |
| 00889024147881 | K101229 | 000 |
| 00889024147874 | K101229 | 000 |
| 00889024147867 | K101229 | 000 |
| 00889024147850 | K101229 | 000 |
| 00889024147492 | K101229 | 000 |
| 00889024153998 | K101229 | 000 |
| 00889024153981 | K101229 | 000 |
| 00889024153974 | K101229 | 000 |
| 00889024153967 | K101229 | 000 |
| 00889024153950 | K101229 | 000 |
| 00889024153943 | K101229 | 000 |
| 00889024153936 | K101229 | 000 |
| 00889024153929 | K101229 | 000 |
| 00889024153912 | K101229 | 000 |
| 00889024153905 | K101229 | 000 |
| 00889024147904 | K101229 | 000 |
| 00889024147911 | K101229 | 000 |
| 00889024147928 | K101229 | 000 |
| 00889024152519 | K101229 | 000 |
| 00889024151239 | K101229 | 000 |
| 00889024151222 | K101229 | 000 |
| 00889024150065 | K101229 | 000 |
| 00889024150058 | K101229 | 000 |
| 00889024150041 | K101229 | 000 |
| 00889024150034 | K101229 | 000 |
| 00889024150027 | K101229 | 000 |
| 00889024150010 | K101229 | 000 |
| 00889024150003 | K101229 | 000 |
| 00889024149991 | K101229 | 000 |
| 00889024149984 | K101229 | 000 |
| 00889024149977 | K101229 | 000 |
| 00889024149618 | K101229 | 000 |
| 00889024147942 | K101229 | 000 |
| 00889024147935 | K101229 | 000 |
| 00889024153547 | K101229 | 000 |