BonOs® Inject Bone Cement; NEO Pedicle Screw System™

Bone Cement, Posterior Screw Augmentation

Neo Medical SA

The following data is part of a premarket notification filed by Neo Medical Sa with the FDA for Bonos® Inject Bone Cement; Neo Pedicle Screw System™.

Pre-market Notification Details

• Device ID: K222256
• 510k Number: K222256
• Device Name: BonOs® Inject Bone Cement; NEO Pedicle Screw System™
• Classification: Bone Cement, Posterior Screw Augmentation
• Applicant: Neo Medical SA Route De Lausanne 157 A Villette (Lavaux), CH 1096
• Contact: Jonas Larsson
• Correspondent: Sandra Soniec; meditec Consulting GmbH Obermoosstrasse 23 Boll, CH 3067
• Product Code: PML
• Subsequent Product Code: NDN
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3027 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-27
• Decision Date: 2022-08-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640177821225	K222256	000
07640177821218	K222256	000
07640177821195	K222256	000
07640177821058	K222256	000
07640177821041	K222256	000
07640177821034	K222256	000
07640177821027	K222256	000
07640177820839	K222256	000
07640177820822	K222256	000