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FDA 510(k)

Blustone Synergy Interbody Fusion System

K-Number: K203520 · 2021-04-07

ApplicantBlustone Synergy, LLC
Decision Date2021-04-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Blustone Synergy Interbody Fusion System is a medical device manufactured by Blustone Synergy, LLC. It received FDA 510(k) clearance on 2021-04-07 under approval number K203520. 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 Blustone Synergy Interbody Fusion System?

Blustone Synergy Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2021-04-07. It is manufactured by Blustone Synergy, LLC. The 510(k) number is K203520.

When was Blustone Synergy Interbody Fusion System approved by the FDA?

Blustone Synergy Interbody Fusion System received FDA 510(k) clearance on 2021-04-07, under approval number K203520.

What company makes Blustone Synergy Interbody Fusion System?

Blustone Synergy Interbody Fusion System is manufactured by Blustone Synergy, LLC.

What is the FDA product code for Blustone Synergy Interbody Fusion System?

The FDA product code for Blustone Synergy Interbody Fusion System is ODP.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING 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 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: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024)

Other Devices by Blustone Synergy, LLC

K210382Blustone Synergy Diamond SA Cervical System

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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