Infinity™ OCT System And PASS OCT Spinal System

Posterior Cervical Screw System

Medicrea International

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

Pre-market Notification Details

• Device ID: K220810
• 510k Number: K220810
• Device Name: Infinity™ OCT System And PASS OCT Spinal System
• Classification: Posterior Cervical 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: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-21
• Decision Date: 2022-04-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03613720287674	K220810	000
03613720289852	K220810	000
03613720289876	K220810	000
03613720289890	K220810	000
03613720289913	K220810	000
03613720289937	K220810	000
03613720289951	K220810	000
03613720289975	K220810	000
03613720289999	K220810	000
03613720290018	K220810	000
03613720287650	K220810	000
03613720289838	K220810	000