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FDA 510(k)

SAGICO Spinal System

K-Number: K223143 · 2023-06-26

ApplicantSagico VA USA, LLC
Decision Date2023-06-26
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAGICO Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K223143. 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 SAGICO Spinal System?

SAGICO Spinal System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Sagico VA USA, LLC. The 510(k) number is K223143.

When did SAGICO Spinal System receive FDA 510(k) clearance?

SAGICO Spinal System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K223143.

Who is the listed applicant for SAGICO Spinal System?

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

What is the FDA product code for SAGICO Spinal System?

The FDA product code for SAGICO Spinal System is OVE.

Other records listing Sagico VA USA, 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.

K232561Ripley Spinal Screw System by SAGICOK221138Titus Titanium Cervical by SAGICO

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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