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