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510(k) K233594

Device
Genesys Spine 3DP AIS-C II Cervical Interbody System
Applicant
Genesys Spine
510(k) number
K233594
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-13
Date received
2023-11-08
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Andrew Davison
Address
1250 S. Capital Of Texas Hwy. Bldg. 3, Suite 600 Austin TX US 78746 78746

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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K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis2025-09-25
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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