FDA 510(k)

ProAM ACDF System

K-Number: K242517 · 2024-11-20

Decision Date2024-11-20

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ProAM ACDF System is the device name listed in this FDA 510(k) record. The listed applicant is Pro Surgical, Inc.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) 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. The listed applicant is Pro Surgical, Inc.. The 510(k) number is K242517.

When did ProAM ACDF System receive FDA 510(k) clearance?

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

Who is the listed applicant for ProAM ACDF System?

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

What is the FDA product code for ProAM ACDF System?

The FDA product code for ProAM ACDF System is OVE.

Other records listing Pro Surgical, 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.

K251644ProAM ALIF System K240126ProAM ALIF System

Related Devices (Code: OVE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.