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FDA 510(k)

IdentiTi ALIF Interbody Systems

K-Number: K232097 · 2023-09-25

ApplicantAlphatec Spine, Inc.
Decision Date2023-09-25
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IdentiTi ALIF Interbody Systems 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 2023-09-25 under 510(k) number K232097. 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 ALIF Interbody Systems?

IdentiTi ALIF Interbody Systems is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232097.

When did IdentiTi ALIF Interbody Systems receive FDA 510(k) clearance?

IdentiTi ALIF Interbody Systems received FDA 510(k) clearance on 2023-09-25, under 510(k) number K232097.

Who is the listed applicant for IdentiTi ALIF Interbody Systems?

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 ALIF Interbody Systems?

The FDA product code for IdentiTi ALIF Interbody Systems is OVD.

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.

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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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