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FDA 510(k) Applications Submitted by LAUREN KAMER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190360
02/15/2019
LineSiderÖ Spinal System
Integrity Implants, Inc
K131321
05/08/2013
CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA
K201367
05/22/2020
FlareHawk TiHawk9 Interbody Fusion System
Integrity Implants Inc.
K131669
06/07/2013
PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK USA, INC.
K121982
07/06/2012
SOVEREIGN SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK
K212088
07/06/2021
Integrity Implants Navigated Instruments
Integrity Implants Inc.
K132111
07/09/2013
CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA
K202198
08/05/2020
FlareHawk Interbody Fusion System
Integrity Implants Inc.
K182114
08/06/2018
FlareHawk Interbody Fusion System
Integrity Implants Inc
K203038
10/06/2020
Toro-L Interbody Fusion System
Integrity Implants Inc
K203367
11/16/2020
LineSiderÖ Spinal System
Integrity Implants Inc.
K183184
11/19/2018
FlareHawk Interbody Fusion System
Integrity Implants Inc
K113642
12/12/2011
PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK USA
K123978
12/26/2012
CAPSTONE L SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA
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