PASS LP™ Spinal System, CD Horizon™ Spinal System

Thoracolumbosacral Pedicle Screw System

Medicrea International SA

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

Pre-market Notification Details

• Device ID: K213281
• 510k Number: K213281
• Device Name: PASS LP™ Spinal System, CD Horizon™ Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medicrea International SA 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140
• Contact: Karine Trogneux
• Correspondent: Karine Trogneux; Medicrea International SA 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-10-01
• Decision Date: 2022-01-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03613720287063	K213281	000
03613720286967	K213281	000
03613720286974	K213281	000
03613720286981	K213281	000
03613720286998	K213281	000
03613720287001	K213281	000
03613720287018	K213281	000
03613720287025	K213281	000
03613720287032	K213281	000
03613720287049	K213281	000
03613720287056	K213281	000
03613720286950	K213281	000