The following data is part of a premarket notification filed by Ncs Lab Srl with the FDA for Elite Spk, Compasso, Elite Spk Kit.
| Device ID | K160500 |
| 510k Number | K160500 |
| Device Name: | Elite SPK, Compasso, Elite SPK Kit |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | NCS Lab Srl Via Pola Esterna 4/12 Carpi, MO 41012 |
| Contact | Matteo Mantovani |
| Correspondent | Christine Brauer Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-23 |
| Decision Date | 2016-04-20 |
| Summary: | summary |