FDA 510(k) Applications Submitted by DONNA SEMLAK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100807 |
03/22/2010 |
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 |
AMERICAN MEDICAL SYSTEMS, INC. |
| K181660 |
06/25/2018 |
Acapella Choice Blue Vibratory PEP Device |
Smiths Medical |
| K132790 |
09/06/2013 |
INFIX ANTERIOR LUMBAR SYSTEM |
ZIMMER SPINE, INC |
| K132894 |
09/16/2013 |
OPTIO-C ANTERIOR CERVICAL SYSTEM |
ZIMMER SPINE, INC. |
| K140611 |
03/10/2014 |
TRINICA ANTERIOR LUMBAR PLATE SYSTEM |
ZIMMER SPINE, INC. |
| K141500 |
06/06/2014 |
OPTIO-C ANTERIOR CERVICAL SYSTEM |
ZIMMER SPINE, INC. |
| K150896 |
04/02/2015 |
Vitality Spinal Fixation System |
ZIMMER SPINE, INC. |
| K151031 |
04/17/2015 |
Virage OCT Spinal Fixation System |
ZIMMER SPINE, INC |
| K181699 |
06/27/2018 |
Level 1 Convective Warmer |
Smiths Medical ASD, Inc. |
| K142752 |
09/24/2014 |
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360║ Spinal Fixatoin System, Title 2 Polyaxial Spinal System |
ZIMMER SPINE, INC. |
| K173384 |
10/30/2017 |
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube |
Smiths Medical ADS, Inc. |
| K143297 |
11/17/2014 |
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) |
Zimmer Spine, Inc. |
| K143626 |
12/22/2014 |
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele |
Zimmer Spine, Inc. |
| K173912 |
12/22/2017 |
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Trache |
Smiths Medical ASD, Inc. |
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