Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALIGN RADIAL HEAD SYSTEM

K-Number: K092721 · 2010-08-03

ApplicantSkeletal Dynamics, LLC
Decision Date2010-08-03
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, LLC. It received FDA 510(k) clearance on 2010-08-03 under 510(k) number K092721. 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 2010-08-03. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K092721.

When did ALIGN RADIAL HEAD SYSTEM receive FDA 510(k) clearance?

ALIGN RADIAL HEAD SYSTEM received FDA 510(k) clearance on 2010-08-03, under 510(k) number K092721.

Who is the listed applicant for ALIGN RADIAL HEAD SYSTEM?

The FDA 510(k) record lists Skeletal Dynamics, LLC 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.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Skeletal Dynamics, LLC 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.

K182492Geminus Volar Distal Radius Plate SystemK180744Stablyx CMC Arthroplasty Implant SystemK172688Align Radial Head SystemK171590Distal Elbow Plating SystemK122310GEMINUS FOSSA SPECIFIC PLATE SYSTEMK122737GEMINUS FOSSA SPECIFIC PLATE SYSTEM

View all 13 devices →

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, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, 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.

↑