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FDA 510(k)

IdentiTi Cervical Standalone Interbody System

K-Number: K202812 · 2020-12-18

ApplicantAlphatec Spine, Inc.
Decision Date2020-12-18
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IdentiTi Cervical Standalone Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K202812. 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 IdentiTi Cervical Standalone Interbody System?

IdentiTi Cervical Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K202812.

When did IdentiTi Cervical Standalone Interbody System receive FDA 510(k) clearance?

IdentiTi Cervical Standalone Interbody System received FDA 510(k) clearance on 2020-12-18, under 510(k) number K202812.

Who is the listed applicant for IdentiTi Cervical Standalone Interbody System?

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

What is the FDA product code for IdentiTi Cervical Standalone Interbody System?

The FDA product code for IdentiTi Cervical Standalone Interbody System is OVE.

Other records listing Alphatec Spine, Inc. 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.

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemK253216IntraOp Alignment System; CONTOUR3D Bending SystemK253615Invictus Bands SystemK252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix SystemK251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody 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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