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FDA 510(k)

ALIGN Radial Head System

K-Number: K231188 · 2023-09-28

ApplicantSkeletal Dynamics, Inc.
Decision Date2023-09-28
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALIGN Radial Head System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-09-28 under approval number K231188. 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 2023-09-28. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K231188.

When was ALIGN Radial Head System approved by the FDA?

ALIGN Radial Head System received FDA 510(k) clearance on 2023-09-28, under approval number K231188.

What company makes ALIGN Radial Head System?

ALIGN Radial Head System is manufactured by Skeletal Dynamics, Inc..

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

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

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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, Inc.

K201962Skeletal Dynamics Ulnar Shortening Plating System K201662REDUCT® Headless Compression Screw System K200538Skeletal Dynamics Forearm Plating System K200701Skeletal Dynamics Midshaft Humerus Plating System K200367Distal Humerus Plating System K211439Small Bone Nailing System

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Related Devices (Code: KWI)

K172688Align Radial Head SystemSkeletal Dynamics, LLC K183618Revolution Radial HeadIgnite Orthopedics, Inc. K192754Avenger Radial Head SystemIn2bones USA, LLC K212872Avenger Radial Head SystemIn2bones USA, LLC K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes 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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