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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 the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-09-28 under 510(k) 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. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K231188.

When did ALIGN Radial Head System receive FDA 510(k) clearance?

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

Who is the listed applicant for ALIGN Radial Head System?

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

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

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

Other records listing Skeletal Dynamics, Inc. as applicant

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Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLCK183618Revolution Radial HeadIgnite Orthopedics, 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.

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