ALLY™ Facet Screws

System, Facet Screw Spinal Device

PROVIDENCE MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Ally™ Facet Screws.

Pre-market Notification Details

• Device ID: K163374
• 510k Number: K163374
• Device Name: ALLY™ Facet Screws
• Classification: System, Facet Screw Spinal Device
• Applicant: PROVIDENCE MEDICAL TECHNOLOGY, INC. 1331 N. CALIFORNIA BLVD. SUITE 320 Walnut Creek, CA 94596
• Contact: Margaret Wong
• Correspondent: Edward Liou; PROVIDENCE MEDICAL TECHNOLOGY, INC. 1331 North California Boulevard, Suite 320 Walnut Creek, CA 94596
• Product Code: MRW
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-01
• Decision Date: 2017-02-16
• Summary: summary