Cleared Traditional

K232780 - CC-Clip® Implant System (FDA 510(k) Clearance)

K232780 · Cc-Instruments, Inc. · Orthopedic device

Dec 2023

Decision

98d

Days

Class 2

Risk

K232780 is an FDA 510(k) clearance for the CC-Clip® Implant System. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by Cc-Instruments, Inc. (Dover, US). The FDA issued a Cleared decision on December 18, 2023, 98 days after receiving the submission on September 11, 2023.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K232780 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 11, 2023
Decision Date	December 18, 2023
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF