FDA.reportPublic FDA data

510(k) K223105

Device
Tesera-K SC System
Applicant
Kyocera Medical Technologies, Inc.
510(k) number
K223105
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-22
Date received
2022-09-30
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Scott Rucker
Address
1200 California St. Suite 210 Redlands CA US 92374 92374

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVE#

510(k), Device, Applicant table
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K250540SABER-C SystemElevation Spine2025-08-08
K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC2025-07-30
K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation2025-06-27
K251117Cervical Spine Truss System (CSTS)4Web Medical2025-04-25
K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.2025-04-10
K243188CYLOX® STSignus Medizintechnik GmbH2025-02-11
K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine2025-02-07
K242517ProAM ACDF SystemPro Surgical, Inc.2024-11-20