FDA.reportPublic FDA data

510(k) K232150

Device
ZSFab Cervical Interbody System
Applicant
Zsfab, Inc.
510(k) number
K232150
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-18
Date received
2023-07-19
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xuewei Ma
Address
96 Clematis Ave. Suite 2f Waltham MA US 02453 02453

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K242303MOD-COrthomod, LLC2026-04-01
K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine2026-03-30
K252432Flex-Z™ Cervical CageSpinepoint, LLC2026-03-25
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K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2026-01-16
K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.2026-01-15
K252219Cervical Interbody and VBR Fusion SystemSync Surgical2026-01-14
K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies2026-01-08
K252894aprevo® cervical interbody systemCarlsmed, Inc.2026-01-06
K252781MSFX MIKRON PEEK CAGESMikron Makina Sanayi VE Tic. Ltd. Sti.2025-12-19