COFLEX-F
Appliance, Fixation, Spinal Interlaminal
PARADIGM SPINE, LLC
The following data is part of a premarket notification filed by Paradigm Spine, Llc with the FDA for Coflex-f.
Pre-market Notification Details
| Device ID | K112595 |
| 510k Number | K112595 |
| Device Name: | COFLEX-F |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | PARADIGM SPINE, LLC 505 PARK AVENUE, 14TH FLOOR New York, NY 10022 |
| Contact | Marc Viscogliosi |
| Correspondent | Marc Viscogliosi PARADIGM SPINE, LLC 505 PARK AVENUE, 14TH FLOOR New York, NY 10022 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2012-02-13 |
| Summary: | summary |
Trademark Results [COFLEX-F]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COFLEX-F 77942097 3955728 Live/Registered |
Paradigm Spine, LLC 2010-02-23 |
 COFLEX-F 77027203 not registered Dead/Abandoned |
Paradigm Spine, LLC 2006-10-23 |
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