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510(k) K203076

Device
Mecta-C Stand Alone Extension
Applicant
Medacta International SA
510(k) number
K203076
Product code
OVE  
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-06
Date received
2020-10-13
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
Stefano Baj
Address
Strada Regina Castel San Pietro (Ch) CH CH-6874 CH-6874

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261279DeltaNEC Interbody SystemNexus Spine2026-06-22
K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.2026-06-18
K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.2026-06-15
K260660SABER-C SystemElevation Spine2026-04-27
K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-20
K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-15
K260038E3D™-C Interbody SystemEvolution Spine2026-02-04
K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.2025-12-22
K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.2025-12-11
K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis2025-09-25
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

Legacy Summary#

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FDA Review#

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