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FDA 510(k)

Accu-Joint Hemi Implant

K-Number: K200951 · 2020-12-08

ApplicantAccufix Surgical, Inc.
Decision Date2020-12-08
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Accu-Joint Hemi Implant is the device name listed in this FDA 510(k) record. The listed applicant is Accufix Surgical, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K200951. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accu-Joint Hemi Implant?

Accu-Joint Hemi Implant is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Accufix Surgical, Inc.. The 510(k) number is K200951.

When did Accu-Joint Hemi Implant receive FDA 510(k) clearance?

Accu-Joint Hemi Implant received FDA 510(k) clearance on 2020-12-08, under 510(k) number K200951.

Who is the listed applicant for Accu-Joint Hemi Implant?

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

What is the FDA product code for Accu-Joint Hemi Implant?

The FDA product code for Accu-Joint Hemi Implant is KWD.

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.

NCT06467760Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx ImplantTERMINATEDNCT07104279Z1 Hip System: Post-Market Clinical Follow Up StudyRECRUITING

Other records listing Accufix Surgical, Inc. 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.

K240268Accu-Joint Hemi Implant

Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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