ORTHOLOC™ 2 Lapidus With Rotation System
Plate, Fixation, Bone
Wright Medical Technology, Inc.
The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc™ 2 Lapidus With Rotation System.
Pre-market Notification Details
| Device ID | K190670 |
| 510k Number | K190670 |
| Device Name: | ORTHOLOC™ 2 Lapidus With Rotation System |
| Classification | Plate, Fixation, Bone |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Alayne Melancon |
| Correspondent | Alayne Melancon Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-05-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797077835 | K190670 | 000 |
| 00889797076739 | K190670 | 000 |
| 00889797076746 | K190670 | 000 |
| 00889797076777 | K190670 | 000 |
| 00889797076784 | K190670 | 000 |
| 00889797076791 | K190670 | 000 |
| 00889797076807 | K190670 | 000 |
| 00889797076814 | K190670 | 000 |
| 00889797076821 | K190670 | 000 |
| 00889797077750 | K190670 | 000 |
| 00889797077767 | K190670 | 000 |
| 00889797077774 | K190670 | 000 |
| 00889797077781 | K190670 | 000 |
| 00889797077798 | K190670 | 000 |
| 00889797077804 | K190670 | 000 |
| 00889797077811 | K190670 | 000 |
| 00889797077828 | K190670 | 000 |
| 00889797076722 | K190670 | 000 |
Trademark Results [ORTHOLOC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOLOC 77636931 4222143 Live/Registered |
Wright Medical Technology, Inc. 2008-12-19 |
 ORTHOLOC 73596966 1417357 Live/Registered |
DOW CORNING CORPORATION 1986-05-05 |
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