The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5mm Tivanium Ti-6al-4v.
| Device ID | K081759 |
| 510k Number | K081759 |
| Device Name: | NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Eric S Pittman |
| Correspondent | Eric S Pittman ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-20 |
| Decision Date | 2008-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024061873 | K081759 | 000 |
| 00889024092662 | K081759 | 000 |
| 00889024092648 | K081759 | 000 |
| 00889024092624 | K081759 | 000 |
| 00889024092600 | K081759 | 000 |
| 00889024092587 | K081759 | 000 |
| 00889024092563 | K081759 | 000 |
| 00889024092549 | K081759 | 000 |
| 00889024092525 | K081759 | 000 |
| 00889024092501 | K081759 | 000 |
| 00889024092488 | K081759 | 000 |
| 00889024092464 | K081759 | 000 |
| 00889024092440 | K081759 | 000 |
| 00889024092426 | K081759 | 000 |
| 00889024292666 | K081759 | 000 |
| 00889024292659 | K081759 | 000 |
| 00889024292642 | K081759 | 000 |
| 00889024092686 | K081759 | 000 |
| 00889024092709 | K081759 | 000 |
| 00889024061859 | K081759 | 000 |
| 00889024061835 | K081759 | 000 |
| 00889024061811 | K081759 | 000 |
| 00889024061798 | K081759 | 000 |
| 00889024061774 | K081759 | 000 |
| 00889024061750 | K081759 | 000 |
| 00889024061736 | K081759 | 000 |
| 00889024061712 | K081759 | 000 |
| 00889024061699 | K081759 | 000 |
| 00889024061675 | K081759 | 000 |
| 00889024061651 | K081759 | 000 |
| 00889024061637 | K081759 | 000 |
| 00889024061613 | K081759 | 000 |
| 00889024061590 | K081759 | 000 |
| 00889024061576 | K081759 | 000 |
| 00889024092723 | K081759 | 000 |
| 00889024297128 | K081759 | 000 |