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FDA 510(k)

ProAM ALIF System

K-Number: K251644 · 2025-06-24

ApplicantPro Surgical, Inc.
Decision Date2025-06-24
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ProAM ALIF System is a medical device manufactured by Pro Surgical, Inc.. It received FDA 510(k) clearance on 2025-06-24 under approval number K251644. 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 ProAM ALIF System?

ProAM ALIF System is a medical device that received FDA 510(k) clearance on 2025-06-24. It is manufactured by Pro Surgical, Inc.. The 510(k) number is K251644.

When was ProAM ALIF System approved by the FDA?

ProAM ALIF System received FDA 510(k) clearance on 2025-06-24, under approval number K251644.

What company makes ProAM ALIF System?

ProAM ALIF System is manufactured by Pro Surgical, Inc..

What is the FDA product code for ProAM ALIF System?

The FDA product code for ProAM ALIF System is OVD.

Other Devices by Pro Surgical, Inc.

K242517ProAM ACDF System K240126ProAM ALIF System

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ 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.

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