STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)

Cement, Bone, Vertebroplasty

DFINE, INC.

The following data is part of a premarket notification filed by Dfine, Inc. with the FDA for Stabili Erx Bone Cement, Model 1135,stabilit Vertebral Augmentation System (for Use W/ Stabilit Erx Bone Cement).

Pre-market Notification Details

• Device ID: K090986
• 510k Number: K090986
• Device Name: STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
• Classification: Cement, Bone, Vertebroplasty
• Applicant: DFINE, INC. 3047 ORCHARD PKWY. San Jose, CA 95134
• Contact: Sandeep Saboo
• Correspondent: Sandeep Saboo; DFINE, INC. 3047 ORCHARD PKWY. San Jose, CA 95134
• Product Code: NDN
• CFR Regulation Number: 888.3027 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-07
• Decision Date: 2009-12-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450296407	K090986	000
10884450296155	K090986	000