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FDA 510(k)

Cervical Interbody and VBR Fusion System

K-Number: K252219 · 2026-01-14

ApplicantSync Surgical
Decision Date2026-01-14
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Interbody and VBR Fusion System is a medical device manufactured by Sync Surgical. It received FDA 510(k) clearance on 2026-01-14 under approval number K252219. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervical Interbody and VBR Fusion System?

Cervical Interbody and VBR Fusion System is a medical device that received FDA 510(k) clearance on 2026-01-14. It is manufactured by Sync Surgical. The 510(k) number is K252219.

When was Cervical Interbody and VBR Fusion System approved by the FDA?

Cervical Interbody and VBR Fusion System received FDA 510(k) clearance on 2026-01-14, under approval number K252219.

What company makes Cervical Interbody and VBR Fusion System?

Cervical Interbody and VBR Fusion System is manufactured by Sync Surgical.

What is the FDA product code for Cervical Interbody and VBR Fusion System?

The FDA product code for Cervical Interbody and VBR Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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