REDUCT® Headless Compression Screw System

Screw, Fixation, Bone

Skeletal Dynamics, Inc.

The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Reduct® Headless Compression Screw System.

Pre-market Notification Details

• Device ID: K201662
• 510k Number: K201662
• Device Name: REDUCT® Headless Compression Screw System
• Classification: Screw, Fixation, Bone
• Applicant: Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156
• Contact: Diana Taylor
• Correspondent: Diana Taylor; Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-19
• Decision Date: 2020-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841506117133	K201662	000
00841506115726	K201662	000
00841506116341	K201662	000