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FDA 510(k)

Align Cervical Interbody Fusion System

K-Number: K230639 · 2023-12-01

ApplicantAcuity Surgical Devices, LLC
Decision Date2023-12-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Align Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230639. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Align Cervical Interbody Fusion System?

Align Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K230639.

When did Align Cervical Interbody Fusion System receive FDA 510(k) clearance?

Align Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230639.

Who is the listed applicant for Align Cervical Interbody Fusion System?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Align Cervical Interbody Fusion System?

The FDA product code for Align Cervical Interbody Fusion System is ODP.

Related Clinical Trials

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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Acuity Surgical Devices, 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.

K251735Stabilis SA Cervical Stand-Alone System (Various PNs)K251335Tera Lumbar Interbody Fusion System (Various PNs)K243386Ventris Intervertebral Body Fusion DeviceK241413sagAlign Lumbar Cage System (Various PNs)K222561AlignK221535Align Lumbar Interbody Fusion System

View all 8 devices →

Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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