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FDA 510(k)

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM

K-Number: K112030 · 2012-06-19

ApplicantSynthes USA, LLC
Decision Date2012-06-19
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA, LLC. It received FDA 510(k) clearance on 2012-06-19 under 510(k) number K112030. 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 SYNTHES RADIAL HEAD PROSTHESIS SYSTEM?

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-19. The listed applicant is Synthes USA, LLC. The 510(k) number is K112030.

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

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM received FDA 510(k) clearance on 2012-06-19, under 510(k) number K112030.

Who is the listed applicant for SYNTHES RADIAL HEAD PROSTHESIS SYSTEM?

The FDA 510(k) record lists Synthes USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES RADIAL HEAD PROSTHESIS SYSTEM?

The FDA product code for SYNTHES RADIAL HEAD PROSTHESIS SYSTEM is KWI.

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Other records listing Synthes USA, 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.

K180821TruMatch Graft Cage - Long BoneK161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemK130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEMK120275SYNTHES ACIS/VERTEBRAL SPACER CRK1015362.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM

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.

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