JointPoint

System, Image Processing, Radiological

JOINTPOINT, INC.

The following data is part of a premarket notification filed by Jointpoint, Inc. with the FDA for Jointpoint.

Pre-market Notification Details

• Device ID: K160284
• 510k Number: K160284
• Device Name: JointPoint
• Classification: System, Image Processing, Radiological
• Applicant: JOINTPOINT, INC. 402 BUTTONWOOD LANE Largo, FL 33770
• Contact: Noah D. Wollowick
• Correspondent: Michelle Mcdonough; MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS LLC 1331 H STREET, NW, 12TH FLOOR Washington, DC 20005
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-03
• Decision Date: 2016-08-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295532040	K160284	000
10603295522850	K160284	000