The following data is part of a premarket notification filed by K2m with the FDA for K2m Fenestrated Tap System.
| Device ID | K152872 |
| 510k Number | K152872 |
| Device Name: | K2M Fenestrated Tap System |
| Classification | Instrument, Biopsy |
| Applicant | K2M 751 MILLER DRIVE SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 751 MILLER DRIVE SE Leesburg, VA 20175 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857183148 | K152872 | 000 |
| 10888857530058 | K152872 | 000 |
| 10888857530065 | K152872 | 000 |
| 10888857530072 | K152872 | 000 |
| 10888857530089 | K152872 | 000 |
| 10888857530096 | K152872 | 000 |
| 10888857461284 | K152872 | 000 |
| 10888857461291 | K152872 | 000 |
| 10888857461307 | K152872 | 000 |
| 10888857461314 | K152872 | 000 |
| 10888857461321 | K152872 | 000 |
| 10888857461338 | K152872 | 000 |
| 10888857183094 | K152872 | 000 |
| 10888857183100 | K152872 | 000 |
| 10888857183117 | K152872 | 000 |
| 10888857183124 | K152872 | 000 |
| 10888857183131 | K152872 | 000 |
| 10888857530041 | K152872 | 000 |