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FDA 510(k)

Tailored-H Cervical Stand Alone System

K-Number: K222903 · 2022-11-18

ApplicantBespoke Technologies, LLC
Decision Date2022-11-18
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tailored-H Cervical Stand Alone System is the device name listed in this FDA 510(k) record. The listed applicant is Bespoke Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222903. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tailored-H Cervical Stand Alone System?

Tailored-H Cervical Stand Alone System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Bespoke Technologies, LLC. The 510(k) number is K222903.

When did Tailored-H Cervical Stand Alone System receive FDA 510(k) clearance?

Tailored-H Cervical Stand Alone System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222903.

Who is the listed applicant for Tailored-H Cervical Stand Alone System?

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

What is the FDA product code for Tailored-H Cervical Stand Alone System?

The FDA product code for Tailored-H Cervical Stand Alone System is OVE.

Related Clinical Trials

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NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Bespoke Technologies, 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.

K200458Tailored-C Cervical Interbody Fusion System

Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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