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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 a medical device manufactured by Accufix Surgical, Inc.. It received FDA 510(k) clearance on 2020-12-08 under approval 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. It is manufactured by Accufix Surgical, Inc.. The 510(k) number is K200951.

When was Accu-Joint Hemi Implant approved by the FDA?

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

What company makes Accu-Joint Hemi Implant?

Accu-Joint Hemi Implant is manufactured by Accufix Surgical, Inc..

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

NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT04251377 Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection ACTIVE_NOT_RECRUITING NCT05439330 Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment Planning RECRUITING NCT07563803 The restor3d Outcomes Registry NOT_YET_RECRUITING NCT07565545 Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes NOT_YET_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Accufix Surgical, Inc.

K240268Accu-Joint Hemi Implant

Related Devices (Code: KWD)

K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc. K190261BOSS Toe Fixation SystemArthrosurface, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K222964BioPoly Lesser Toe Hemiarthroplasty 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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