FDA 510(k)

Align

K-Number: K222561 · 2022-09-23

Decision Date2022-09-23

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Align is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2022-09-23 under approval number K222561. 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 Align?

Align is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K222561.

When was Align approved by the FDA?

Align received FDA 510(k) clearance on 2022-09-23, under approval number K222561.

What company makes Align?

Align is manufactured by Acuity Surgical Devices, LLC.

What is the FDA product code for Align?

The FDA product code for Align is OVD.

Other Devices by Acuity Surgical Devices, LLC

K201671A-Link Z K221535Align Lumbar Interbody Fusion System K230639Align Cervical Interbody Fusion System K241413sagAlign Lumbar Cage System (Various PNs) K251735Stabilis SA Cervical Stand-Alone System (Various PNs) K251335Tera Lumbar Interbody Fusion System (Various PNs)

View all 8 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.