Cleared Traditional

Accu-Joint Hemi Implant

K200951 · Accufix Surgical, Inc. · Orthopedic

Dec 2020

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K200951 is an FDA 510(k) clearance for the Accu-Joint Hemi Implant, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Accufix Surgical, Inc. (West Haven, US). The FDA issued a Cleared decision on December 8, 2020, 243 days after receiving the submission on April 9, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number	K200951 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2020
Decision Date	December 08, 2020
Days to Decision	243 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF