The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen.
| Device ID | K110940 |
| 510k Number | K110940 |
| Device Name: | ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KRO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024195813 | K110940 | 000 |
| 00889024196452 | K110940 | 000 |
| 00889024196476 | K110940 | 000 |
| 00889024196483 | K110940 | 000 |
| 00889024196490 | K110940 | 000 |
| 00889024196506 | K110940 | 000 |
| 00889024196513 | K110940 | 000 |
| 00889024196780 | K110940 | 000 |
| 00889024196797 | K110940 | 000 |
| 00889024196445 | K110940 | 000 |
| 00889024196438 | K110940 | 000 |
| 00889024196421 | K110940 | 000 |
| 00889024195820 | K110940 | 000 |
| 00889024195837 | K110940 | 000 |
| 00889024195844 | K110940 | 000 |
| 00889024195851 | K110940 | 000 |
| 00889024196384 | K110940 | 000 |
| 00889024196391 | K110940 | 000 |
| 00889024196407 | K110940 | 000 |
| 00889024196414 | K110940 | 000 |
| 00889024196803 | K110940 | 000 |
| 00889024196810 | K110940 | 000 |
| 00889024197558 | K110940 | 000 |
| 00889024197565 | K110940 | 000 |
| 00889024197602 | K110940 | 000 |
| 00889024196018 | K110940 | 000 |
| 00889024196131 | K110940 | 000 |
| 00889024195592 | K110940 | 000 |
| 00889024195561 | K110940 | 000 |
| 00889024195578 | K110940 | 000 |
| 00889024197169 | K110940 | 000 |
| 00889024197121 | K110940 | 000 |
| 00889024197008 | K110940 | 000 |
| 00889024196827 | K110940 | 000 |
| 00889024196834 | K110940 | 000 |
| 00889024196841 | K110940 | 000 |
| 00889024196858 | K110940 | 000 |
| 00889024196865 | K110940 | 000 |
| 00889024196872 | K110940 | 000 |
| 00889024196889 | K110940 | 000 |
| 00889024196896 | K110940 | 000 |
| 00889024195585 | K110940 | 000 |