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FDA 510(k)

Acapella Cervical Spacer System

K-Number: K171489 · 2017-10-23

ApplicantChoicespine, LP
Decision Date2017-10-23
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acapella Cervical Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K171489. 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 Acapella Cervical Spacer System?

Acapella Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Choicespine, LP. The 510(k) number is K171489.

When did Acapella Cervical Spacer System receive FDA 510(k) clearance?

Acapella Cervical Spacer System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K171489.

Who is the listed applicant for Acapella Cervical Spacer System?

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

What is the FDA product code for Acapella Cervical Spacer System?

The FDA product code for Acapella Cervical Spacer System is OVE.

Other records listing Choicespine, LP 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.

K190227Boomerang™ Anterior Cervical Plate SystemK183397ChoiceSpine Stealth Cervical Spacer SystemK182721Choice Spine Navigation SystemK183214Raven Lumbar Plate SystemK180519HARRIER-SA™ Lumbar Interbody SystemK172816TiGer Shark™ System

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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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