The following data is part of a premarket notification filed by Facet-link, Inc. with the FDA for Facet-link Stabilization Platform.
| Device ID | K150223 |
| 510k Number | K150223 |
| Device Name: | Facet-Link Stabilization Platform |
| Classification | System, Facet Screw Spinal Device |
| Applicant | FACET-LINK, INC. 101 ROUNDHILL DRIVE, 2ND FLOOR Rockaway, NJ 07866 |
| Contact | Massimo Calafiore |
| Correspondent | Janice M Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575421206 | K150223 | 000 |
| 04026575421091 | K150223 | 000 |
| 04026575421107 | K150223 | 000 |
| 04026575421114 | K150223 | 000 |
| 04026575421121 | K150223 | 000 |
| 04026575421138 | K150223 | 000 |
| 04026575421145 | K150223 | 000 |
| 04026575421152 | K150223 | 000 |
| 04026575421169 | K150223 | 000 |
| 04026575421176 | K150223 | 000 |
| 04026575421183 | K150223 | 000 |
| 04026575421190 | K150223 | 000 |
| 04026575420919 | K150223 | 000 |