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FDA 510(k)

ChoiceSpine Blackhawk Ti Cervical Spacer System

K-Number: K223869 · 2023-09-14

ApplicantChoice Spine, LLC
Decision Date2023-09-14
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ChoiceSpine Blackhawk Ti Cervical Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Choice Spine, LLC. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K223869. 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 ChoiceSpine Blackhawk Ti Cervical Spacer System?

ChoiceSpine Blackhawk Ti Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Choice Spine, LLC. The 510(k) number is K223869.

When did ChoiceSpine Blackhawk Ti Cervical Spacer System receive FDA 510(k) clearance?

ChoiceSpine Blackhawk Ti Cervical Spacer System received FDA 510(k) clearance on 2023-09-14, under 510(k) number K223869.

Who is the listed applicant for ChoiceSpine Blackhawk Ti Cervical Spacer System?

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

What is the FDA product code for ChoiceSpine Blackhawk Ti Cervical Spacer System?

The FDA product code for ChoiceSpine Blackhawk Ti Cervical Spacer System is OVE.

Other records listing Choice Spine, 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.

K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemK220024ChoiceSpine Navigation SystemK211449Triton™ Sacroiliac Joint Fixation SystemK203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemK203561ChoiceSpine Navigation SystemK201643ChoiceSpine Tiger Shark Cervical Spacer System

View all 9 devices →

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

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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