CD Horizon™ Spinal System And PASS LP™ Spinal System

Thoracolumbosacral Pedicle Screw System

Medicrea International

The following data is part of a premarket notification filed by Medicrea International with the FDA for Cd Horizon™ Spinal System And Pass Lp™ Spinal System.

Pre-market Notification Details

• Device ID: K220724
• 510k Number: K220724
• Device Name: CD Horizon™ Spinal System And PASS LP™ Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medicrea International 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140
• Contact: Karine Trogneux
• Correspondent: Karine Trogneux; Medicrea International 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-14
• Decision Date: 2022-04-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03613720289432	K220724	000
03613720289678	K220724	000
03613720289692	K220724	000
03613720289715	K220724	000
03613720289739	K220724	000
03613720289753	K220724	000
03613720289777	K220724	000
03613720289791	K220724	000
03613720289814	K220724	000
03613720290032	K220724	000
03613720289654	K220724	000
03613720289630	K220724	000
03613720289456	K220724	000
03613720289470	K220724	000
03613720289494	K220724	000
03613720289517	K220724	000
03613720289531	K220724	000
03613720289555	K220724	000
03613720289579	K220724	000
03613720289593	K220724	000
03613720289616	K220724	000
03613720290056	K220724	000
03613720290070	K220724	000
03613720287520	K220724	000
03613720287537	K220724	000
03613720287568	K220724	000
03613720287575	K220724	000
03613720287582	K220724	000
03613720287599	K220724	000
03613720287605	K220724	000
03613720287612	K220724	000
03613720287629	K220724	000
03613720287513	K220724	000
03613720287506	K220724	000
03613720290094	K220724	000
03613720290117	K220724	000
03613720290131	K220724	000
03613720290155	K220724	000
03613720290179	K220724	000
03613720290193	K220724	000
03613720290216	K220724	000
03613720290230	K220724	000
03613720290254	K220724	000
03613720287636	K220724	000