The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Dual Mobility - Longevity And Vivacit-e Polyethylene Hip Bearings.
| Device ID | K190656 |
| 510k Number | K190656 |
| Device Name: | Dual Mobility - Longevity And Vivacit-E Polyethylene Hip Bearings |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Charles Neitzel |
| Correspondent | Charles Neitzel Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-14 |
| Decision Date | 2019-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024572829 | K190656 | 000 |
| 00889024572652 | K190656 | 000 |
| 00889024572645 | K190656 | 000 |
| 00889024572638 | K190656 | 000 |
| 00889024572621 | K190656 | 000 |
| 00889024572614 | K190656 | 000 |
| 00889024572607 | K190656 | 000 |
| 00889024572591 | K190656 | 000 |
| 00889024572584 | K190656 | 000 |
| 00889024572577 | K190656 | 000 |
| 00889024572560 | K190656 | 000 |
| 00889024572553 | K190656 | 000 |
| 00889024572546 | K190656 | 000 |
| 00889024572539 | K190656 | 000 |
| 00889024572669 | K190656 | 000 |
| 00889024572676 | K190656 | 000 |
| 00889024572683 | K190656 | 000 |
| 00889024572812 | K190656 | 000 |
| 00889024572805 | K190656 | 000 |
| 00889024572799 | K190656 | 000 |
| 00889024572782 | K190656 | 000 |
| 00889024572775 | K190656 | 000 |
| 00889024572768 | K190656 | 000 |
| 00889024572751 | K190656 | 000 |
| 00889024572744 | K190656 | 000 |
| 00889024572737 | K190656 | 000 |
| 00889024572720 | K190656 | 000 |
| 00889024572713 | K190656 | 000 |
| 00889024572706 | K190656 | 000 |
| 00889024572690 | K190656 | 000 |
| 00889024572522 | K190656 | 000 |