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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 the device name listed in this FDA 510(k) record. The listed applicant is Blustone Synergy, LLC. It received FDA 510(k) clearance on 2021-04-07 under 510(k) 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. The listed applicant is Blustone Synergy, LLC. The 510(k) number is K203520.

When did Blustone Synergy Interbody Fusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for Blustone Synergy Interbody Fusion System?

The FDA 510(k) record lists Blustone Synergy, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Blustone Synergy, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210382Blustone Synergy Diamond SA Cervical SystemK172330Blustone Synergy Silica System

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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

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