The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Straight Narrow Shaft Plates.
| Device ID | K113718 |
| 510k Number | K113718 |
| Device Name: | NCB STRAIGHT NARROW SHAFT PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER GMBH PO BOX 708 Warsaw, IN 46581 |
| Contact | Stephen H Mckelvey |
| Correspondent | Stephen H Mckelvey ZIMMER GMBH PO BOX 708 Warsaw, IN 46581 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024484757 | K113718 | 000 |
| 00889024297685 | K113718 | 000 |
| 00889024293021 | K113718 | 000 |
| 00889024293014 | K113718 | 000 |
| 00889024293007 | K113718 | 000 |
| 00889024292994 | K113718 | 000 |
| 00889024292987 | K113718 | 000 |
| 00889024292970 | K113718 | 000 |
| 00889024289963 | K113718 | 000 |
| 00889024297692 | K113718 | 000 |
| 00889024297708 | K113718 | 000 |
| 00889024484740 | K113718 | 000 |
| 00889024484733 | K113718 | 000 |
| 00889024484726 | K113718 | 000 |
| 00889024484719 | K113718 | 000 |
| 00889024484702 | K113718 | 000 |
| 00889024297739 | K113718 | 000 |
| 00889024297722 | K113718 | 000 |
| 00889024297715 | K113718 | 000 |
| 00889024289956 | K113718 | 000 |