FORTRESS™ Radiopaque Bone Cement (FORTRESS™ And FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System

Bone Cement, Posterior Screw Augmentation

Globus Medical, Inc.

The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Fortress™ Radiopaque Bone Cement (fortress™ And Fortress-plus™), Creo® Fenestrated Screw System, Revlok® Fenestrated Screw System.

Pre-market Notification Details

• Device ID: K172269
• 510k Number: K172269
• Device Name: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ And FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
• Classification: Bone Cement, Posterior Screw Augmentation
• Applicant: Globus Medical, Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker; Globus Medical, Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Product Code: PML
• Subsequent Product Code: KWQ
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3027 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-28
• Decision Date: 2018-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889095543674	K172269	000
00889095563900	K172269	000
00889095563887	K172269	000
00889095563801	K172269	000
00889095563788	K172269	000
00889095563764	K172269	000
00889095543735	K172269	000
00889095543711	K172269	000
00889095543698	K172269	000
00889095543636	K172269	000
00889095543575	K172269	000
00889095563986	K172269	000
00889095564006	K172269	000
00889095564044	K172269	000
00889095543650	K172269	000
00889095543612	K172269	000
00889095543599	K172269	000
00889095564266	K172269	000
00889095564242	K172269	000
00889095564204	K172269	000
00889095564167	K172269	000
00889095564129	K172269	000
00889095564105	K172269	000
00889095564068	K172269	000
00889095543551	K172269	000