FACET SCREW SYSTEM

System, Facet Screw Spinal Device

FACET-LINK, INC.

The following data is part of a premarket notification filed by Facet-link, Inc. with the FDA for Facet Screw System.

Pre-market Notification Details

• Device ID: K123497
• 510k Number: K123497
• Device Name: FACET SCREW SYSTEM
• Classification: System, Facet Screw Spinal Device
• Applicant: FACET-LINK, INC. 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103
• Contact: Janice M Hogan
• Correspondent: Janice M Hogan; FACET-LINK, INC. 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103
• 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: 2012-11-13
• Decision Date: 2013-02-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04026575420896	K123497	000
04026575420858	K123497	000
04026575420865	K123497	000
04026575420872	K123497	000
04026575420889	K123497	000
04026575421022	K123497	000
04026575421039	K123497	000
04026575421046	K123497	000
04026575421053	K123497	000
04026575420841	K123497	000
04026575420834	K123497	000
04026575081493	K123497	000
04026575081509	K123497	000
04026575081516	K123497	000
04026575081523	K123497	000
04026575081530	K123497	000
04026575081547	K123497	000
04026575081554	K123497	000
04026575420827	K123497	000
04026575421060	K123497	000
04026575421077	K123497	000
04026575421084	K123497	000
00817329024491	K123497	000
00817329024507	K123497	000
00817329024514	K123497	000
00817329024521	K123497	000
00817329024538	K123497	000
00817329024545	K123497	000
00817329024552	K123497	000
00817329024569	K123497	000
00817329024484	K123497	000
00817329024477	K123497	000
04026575426560	K123497	000
04026575426577	K123497	000
04026575426584	K123497	000
04026575426591	K123497	000
04026575426607	K123497	000
04026575426614	K123497	000
04026575426621	K123497	000
00817329024460	K123497	000
00817329024576	K123497	000