SpaceOAR System

Hydrogel Spacer

AUGMENIX , INC.

The following data is part of a De Novo classification by Augmenix , Inc. with the FDA for Spaceoar System.

Pre-market Notification Details

• DeNovo ID: DEN140030
• Device Name: SpaceOAR System
• Classification: Hydrogel Spacer
• Applicant: AUGMENIX , INC. 204 Second Avenue lower Level Waltham, MA 02451
• Contact: Noel Rolon
• Product Code: OVB
• CFR Regulation Number: 892.5725 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Radiology
• Classification Advisory: Radiology
• Type: Direct
• Date Received: 2014-10-01
• Decision Date: 2015-04-01
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00864661000102	DEN140030	000