The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc® 3di Small Bones Plating.
Device ID | K163039 |
510k Number | K163039 |
Device Name: | ORTHOLOC® 3Di Small Bones Plating |
Classification | Plate, Fixation, Bone |
Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Contact | Michael Mullins |
Correspondent | Michael Mullins 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 | 2016-10-31 |
Decision Date | 2017-03-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840420185471 | K163039 | 000 |
00840420185327 | K163039 | 000 |
00840420185334 | K163039 | 000 |
00840420185341 | K163039 | 000 |
00840420185358 | K163039 | 000 |
00840420185365 | K163039 | 000 |
00840420185372 | K163039 | 000 |
00840420185389 | K163039 | 000 |
00840420185396 | K163039 | 000 |
00840420185402 | K163039 | 000 |
00840420185419 | K163039 | 000 |
00840420185426 | K163039 | 000 |
00840420185433 | K163039 | 000 |
00840420185440 | K163039 | 000 |
00840420185457 | K163039 | 000 |
00840420185464 | K163039 | 000 |
00840420185310 | K163039 | 000 |
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 |