TITAN 3-D™ Wedge System
Bone Wedge
PARAGON 28
The following data is part of a premarket notification filed by Paragon 28 with the FDA for Titan 3-d™ Wedge System.
Pre-market Notification Details
| Device ID | K162241 |
| 510k Number | K162241 |
| Device Name: | TITAN 3-D™ Wedge System |
| Classification | Bone Wedge |
| Applicant | PARAGON 28 4B INVERNESS CT.E., STE 280 Englewood, CO 80112 |
| Contact | Frank S. Bono |
| Correspondent | Karen E. Warden, Ph.d. BACKROADS CONSULTING, INC P.O. BOX 566 Chesterland, OH 44026 -0566 |
| Product Code | PLF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2017-04-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795018236 | K162241 | 000 |
| 00889795020031 | K162241 | 000 |
| 00889795020079 | K162241 | 000 |
| 00889795020086 | K162241 | 000 |
| 00889795020093 | K162241 | 000 |
| 00889795020109 | K162241 | 000 |
| 00889795018120 | K162241 | 000 |
| 00889795018137 | K162241 | 000 |
| 00889795018144 | K162241 | 000 |
| 00889795018151 | K162241 | 000 |
| 00889795018168 | K162241 | 000 |
| 00889795018175 | K162241 | 000 |
| 00889795018182 | K162241 | 000 |
| 00889795018199 | K162241 | 000 |
| 00889795018205 | K162241 | 000 |
| 00889795018212 | K162241 | 000 |
| 00889795018229 | K162241 | 000 |
| 00889795020024 | K162241 | 000 |
Trademark Results [TITAN 3-D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TITAN 3-D 87627686 5604500 Live/Registered |
Paragon 28, Inc. 2017-09-29 |
 TITAN 3-D 87186346 not registered Live/Pending |
PARAGON 28, INC. 2016-09-28 |
TITAN 3-D 87186346 not registered Live/Pending |
Paragon 28, Inc. 2016-09-28 |
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