Cleared Special

Ascension Silicone MCP; Ascension Silicone PIP

K233670 · Ascension Orthopedics, Inc. · Orthopedic
Dec 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K233670 is an FDA 510(k) clearance for the Ascension Silicone MCP; Ascension Silicone PIP, a Prosthesis, Finger, Constrained, Polymer (Class II — Special Controls, product code KYJ), submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on December 14, 2023, 29 days after receiving the submission on November 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3230.

Submission Details

510(k) Number K233670 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2023
Decision Date December 14, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KYJ — Prosthesis, Finger, Constrained, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3230

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