FDA 510(k) Applications Submitted by DALE DAVISON

FDA 510(k) Number Submission Date Device Name Applicant
K120047 01/06/2012 CORAL SPINAL SYSTEM THEKEN SPINE, LLC
K070381 02/08/2007 THEKEN VU MESH VBR SYSTEM THEKEN SPINE LLC
K070638 03/07/2007 THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC
K080690 03/11/2008 MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM THEKEN SPINE LLC
K120829 03/19/2012 STAINLESS STEEL SPINAL SYSTEM THEKEN SPINE, LLC
K080790 03/20/2008 MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC
K070786 03/22/2007 X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT THEKEN SPINE LLC
K080822 03/24/2008 VU APOD INTERVERTABRAL BODY FUSION DEVICE THEKEN SPINE LLC
K070962 04/05/2007 CORAL PEDICLE SCREW SYSTEM THEKEN SPINE LLC
K100970 04/08/2010 STAINLESS STEEL SPINAL SYSTEM THEKEN SPINE LLC
K071031 04/11/2007 VU E*POD VERTEBRAL BODY REPLACEMENT THEKEN SPINE LLC
K121211 04/20/2012 VU APOD INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE, LLC
K161184 04/27/2016 iNSitu Total Hip System Theken Companies, LLC
K091266 04/30/2009 THEKEN CORAL SPINAL SYSTEM THEKEN SPINE LLC
K181287 05/16/2018 Catalyst CSR Shoulder System Catalyst OrthoScience, Inc.
K121482 05/18/2012 INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY THEKEN SPINE LLC
K081414 05/20/2008 MODIFICATION TO CORAL SPINAL SYSTEM THEKEN SPINE LLC
K111675 06/15/2011 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC
K211991 06/28/2021 Catalyst R1 Reverse Shoulder System Catalyst OrthoScience, Inc.
K191811 07/05/2019 Catalyst OrthoScience CSR Shoulder System Catalyst OrthoScience, Inc.
K222317 08/02/2022 Catalyst EA Convertible Stemmed Shoulder Catalyst OrthoScience, Inc.
K102323 08/17/2010 CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC
K172501 08/18/2017 iNSitu Total Hip System Theken Companies, LLC
K232583 08/25/2023 Catalyst R1 Reverse Shoulder System Catalyst OrthoScience, Inc.
K072407 08/27/2007 BODYFORM THORACIC FIXATION SYSTEM THEKEN SPINE LLC
K202611 09/09/2020 Catalyst OrthoScience R1 Reverse Shoulder System Catalyst OrthoScience, Inc.
K182500 09/12/2018 Catalyst CSR Press-Fit Humeral Components Catalyst OrthoScience, Inc.
K082712 09/16/2008 THEKEN SPINE VU EPOD AND VU LPOD SYSTEM THEKEN SPINE LLC
K112986 10/06/2011 LATERAL FUSION DEVICE INTEGRA SPINE (INTEGRA LIFESCIENCES)
K213349 10/08/2021 Catalyst R1 Reverse Shoulder System Catalyst OrthoScience, Inc
K083073 10/15/2008 THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC
K103228 11/02/2010 PARAMOUNT R IBF DEVICE THEKEN SPINE LLC
K223655 12/06/2022 Catalyst R1 Reverse Shoulder System Catalyst OrthoScience, Inc.
K173812 12/15/2017 Catalyst CSR 3 Peg Glenoids Catalyst OrthoScience, Inc
K234105 12/26/2023 Catalyst F1x Shoulder System Catalyst OrthoScience, Inc.
K083863 12/29/2008 THEKEN ATOLL OCT SPINAL SYSTEM THEKEN SPINE LLC


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