FDA.report

510(k) K253876

Device
HEDRON? Cervical Spacers (HEDRON C-MIS? Spacer)
Applicant
Globus Medical, Inc.
510(k) number
K253876
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-22
Date received
2025-12-04
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

Related Records

Applicant Contact

Contact
Jennifer Antonacci
Address
Valley Forge Business Center 2560 General Armistead Ave. Audubon PA US 19403 19403

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00193982684785HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684709HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684716HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684723HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684655HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684648HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684631HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684624HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684617HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684600HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684594HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684587HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684662HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684761HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684778HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684754HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684792HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684808HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982684815HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685072HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685089HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685096HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685102HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685119HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685126HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685133HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685140HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685157HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685164HEDRONGLOBUS MEDICAL, INC.2026-01-27
00193982685171HEDRONGLOBUS MEDICAL, INC.2026-01-27

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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
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K242517ProAM ACDF SystemPro Surgical, Inc.2024-11-20
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