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FDA 510(k)

Align Radial Head System

K-Number: K172688 · 2017-12-22

ApplicantSkeletal Dynamics, LLC
Decision Date2017-12-22
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Align Radial Head System is a medical device manufactured by Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2017-12-22 under approval number K172688. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Align Radial Head System?

Align Radial Head System is a medical device that received FDA 510(k) clearance on 2017-12-22. It is manufactured by Skeletal Dynamics, LLC. The 510(k) number is K172688.

When was Align Radial Head System approved by the FDA?

Align Radial Head System received FDA 510(k) clearance on 2017-12-22, under approval number K172688.

What company makes Align Radial Head System?

Align Radial Head System is manufactured by Skeletal Dynamics, LLC.

What is the FDA product code for Align Radial Head System?

The FDA product code for Align Radial Head System is KWI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Skeletal Dynamics, LLC

K171590Distal Elbow Plating System K182492Geminus Volar Distal Radius Plate System K180744Stablyx CMC Arthroplasty Implant System

Related Devices (Code: KWI)

K183618Revolution Radial HeadIgnite Orthopedics, Inc. K192754Avenger Radial Head SystemIn2bones USA, LLC K212872Avenger Radial Head SystemIn2bones USA, LLC K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc. K233592BioPoly Radial Head ImplantBioPoly, LLC

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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