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FDA 510(k)

Arthrex SS VAL and VAL KreuLock™ Compression Screw System

K-Number: K243195 · 2025-01-10

ApplicantArthrex, Inc.
Decision Date2025-01-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex SS VAL and VAL KreuLock™ Compression Screw System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-01-10 under approval number K243195. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex SS VAL and VAL KreuLock™ Compression Screw System?

Arthrex SS VAL and VAL KreuLock™ Compression Screw System is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Arthrex, Inc.. The 510(k) number is K243195.

When was Arthrex SS VAL and VAL KreuLock™ Compression Screw System approved by the FDA?

Arthrex SS VAL and VAL KreuLock™ Compression Screw System received FDA 510(k) clearance on 2025-01-10, under approval number K243195.

What company makes Arthrex SS VAL and VAL KreuLock™ Compression Screw System?

Arthrex SS VAL and VAL KreuLock™ Compression Screw System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SS VAL and VAL KreuLock™ Compression Screw System?

The FDA product code for Arthrex SS VAL and VAL KreuLock™ Compression Screw System is HWC. This falls under the Cardiovascular category.

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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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