Cleared Traditional

BioPoly Great Toe Hemiarthroplasty Implant

K203634 · BioPoly, LLC · Orthopedic

Feb 2021

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K203634 is an FDA 510(k) clearance for the BioPoly Great Toe Hemiarthroplasty Implant, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by BioPoly, LLC (Fort Wayne, US). The FDA issued a Cleared decision on February 2, 2021, 53 days after receiving the submission on December 11, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number	K203634 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2020
Decision Date	February 02, 2021
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF