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FDA 510(k)

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

K-Number: K251575 · 2025-09-03

ApplicantAlphatec Spine
Decision Date2025-09-03
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K251575. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Alphatec Spine. The 510(k) number is K251575.

When did IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System receive FDA 510(k) clearance?

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System received FDA 510(k) clearance on 2025-09-03, under 510(k) number K251575.

Who is the listed applicant for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

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

What is the FDA product code for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

The FDA product code for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is OVD.

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

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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