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FDA 510(k)

TotalTi ACDF by SAGICO

K-Number: K233191 · 2023-11-21

ApplicantSpinal Analytics & Geometrical Implant Co, LLC
Decision Date2023-11-21
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TotalTi ACDF by SAGICO is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Analytics & Geometrical Implant Co, LLC. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K233191. 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 TotalTi ACDF by SAGICO?

TotalTi ACDF by SAGICO is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Spinal Analytics & Geometrical Implant Co, LLC. The 510(k) number is K233191.

When did TotalTi ACDF by SAGICO receive FDA 510(k) clearance?

TotalTi ACDF by SAGICO received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233191.

Who is the listed applicant for TotalTi ACDF by SAGICO?

The FDA 510(k) record lists Spinal Analytics & Geometrical Implant Co, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TotalTi ACDF by SAGICO?

The FDA product code for TotalTi ACDF by SAGICO is OVE.

Other records listing Spinal Analytics & Geometrical Implant Co, 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.

K180220SAGICO OSI Spinal System by Osimplant

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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