Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ProAM ACDF System

K-Number: K242517 · 2024-11-20

ApplicantPro Surgical, Inc.
Decision Date2024-11-20
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ProAM ACDF System is a medical device manufactured by Pro Surgical, Inc.. It received FDA 510(k) clearance on 2024-11-20 under approval number K242517. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProAM ACDF System?

ProAM ACDF System is a medical device that received FDA 510(k) clearance on 2024-11-20. It is manufactured by Pro Surgical, Inc.. The 510(k) number is K242517.

When was ProAM ACDF System approved by the FDA?

ProAM ACDF System received FDA 510(k) clearance on 2024-11-20, under approval number K242517.

What company makes ProAM ACDF System?

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

What is the FDA product code for ProAM ACDF System?

The FDA product code for ProAM ACDF System is OVE.

Other Devices by Pro Surgical, Inc.

K240126ProAM ALIF System K251644ProAM ALIF System

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.

↑