The following data is part of a premarket notification filed by Paradigm Spine, Llc with the FDA for Coflex-if.
| Device ID | K153302 |
| 510k Number | K153302 |
| Device Name: | Coflex-IF |
| Classification | Spinous Process Plate |
| Applicant | PARADIGM SPINE, LLC 505 PARK AVENUE, 14TH FLOOR New York, NY 10022 |
| Contact | Marc Viscogliosi |
| Correspondent | Justin Eggleton MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260148898273 | K153302 | 000 |
| 04260148898266 | K153302 | 000 |
| 04260148898259 | K153302 | 000 |
| 04260148898242 | K153302 | 000 |
| 04260148898235 | K153302 | 000 |
| 04260636678929 | K153302 | 000 |