Cleared Traditional

KeriFlex? MCP and PIP Finger Joint Prostheses

K211385 · Keri Medical SA · Orthopedic

Jul 2022

Decision

449d

Days

Class 2

Risk

About This 510(k) Submission

K211385 is an FDA 510(k) clearance for the KeriFlex? MCP and PIP Finger Joint Prostheses, a Prosthesis, Finger, Constrained, Polymer (Class II — Special Controls, product code KYJ), submitted by Keri Medical SA (Geneva, CH). The FDA issued a Cleared decision on July 27, 2022, 449 days after receiving the submission on May 4, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3230.

Submission Details

510(k) Number	K211385 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2021
Decision Date	July 27, 2022
Days to Decision	449 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF