RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System

Thoracolumbosacral Pedicle Screw System

OrthoPediatrics, Corp

The following data is part of a premarket notification filed by Orthopediatrics, Corp with the FDA for Response™ Spine System, Response™ 4.5/5.0 Spine System, Response™ 5.5/6.0 Spine System.

Pre-market Notification Details

• Device ID: K193100
• 510k Number: K193100
• Device Name: RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: OrthoPediatrics, Corp 2850 Frontier Drive Warsaw, IN 46582
• Contact: Jackie Jaskula
• Correspondent: Jackie Jaskula; OrthoPediatrics, Corp 2850 Frontier Drive Warsaw, IN 46582
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-08
• Decision Date: 2020-03-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841132174432	K193100	000
00841132178874	K193100	000
00841132184684	K193100	000
00841132184691	K193100	000
00841132184707	K193100	000
00841132184714	K193100	000
00841132184721	K193100	000
00841132139004	K193100	000
00841132139011	K193100	000
00841132139028	K193100	000
00841132178850	K193100	000