The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech® Truliant™ Line Extensions.
Device ID | K171045 |
510k Number | K171045 |
Device Name: | Exactech® Truliant™ Line Extensions |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 |
Contact | Patrick Hughes |
Correspondent | Patrick Hughes Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-07 |
Decision Date | 2017-04-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10885862320650 | K171045 | 000 |
10885862593504 | K171045 | 000 |
10885862593511 | K171045 | 000 |
10885862593528 | K171045 | 000 |
10885862593535 | K171045 | 000 |
10885862593542 | K171045 | 000 |
10885862593559 | K171045 | 000 |
10885862593566 | K171045 | 000 |
10885862593573 | K171045 | 000 |
10885862593597 | K171045 | 000 |
10885862593696 | K171045 | 000 |
10885862228383 | K171045 | 000 |
10885862305916 | K171045 | 000 |
10885862305923 | K171045 | 000 |
10885862306241 | K171045 | 000 |
10885862314468 | K171045 | 000 |
10885862314574 | K171045 | 000 |
10885862314703 | K171045 | 000 |
10885862632913 | K171045 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXACTECH 97543105 not registered Live/Pending |
Exactech, Inc. 2022-08-10 |
EXACTECH 86168270 not registered Dead/Abandoned |
Tyco Fire & Security GMBH 2014-01-17 |
EXACTECH 79175410 4990914 Live/Registered |
Tyco Fire & Security GmbH 2015-08-09 |
EXACTECH 77792130 3877806 Live/Registered |
Exactech, Inc. 2009-07-29 |
EXACTECH 77792119 3868433 Live/Registered |
Exactech, Inc. 2009-07-29 |
EXACTECH 77350327 not registered Dead/Abandoned |
Abbott Laboratories 2007-12-12 |
EXACTECH 75132151 2115548 Dead/Cancelled |
Medisense, Inc. 1996-07-10 |
EXACTECH 73804174 1650672 Dead/Cancelled |
EXACTECH, INC. 1989-06-01 |
EXACTECH 73713884 1509981 Dead/Cancelled |
BAXTER TRAVENOL LABORATORIES, INC. 1988-02-29 |