SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

Orthosis, Spinal Pedicle Fixation

ORTHO TEC LLC

The following data is part of a premarket notification filed by Ortho Tec Llc with the FDA for Scs Claris Spinal System, Lengthened Lateral Connector, Model Al06.

Pre-market Notification Details

• Device ID: K021379
• 510k Number: K021379
• Device Name: SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: ORTHO TEC LLC 8202 SHERMAN RD. Chesterland, OH 44026 -2141
• Contact: Karen E Warden
• Correspondent: Karen E Warden; ORTHO TEC LLC 8202 SHERMAN RD. Chesterland, OH 44026 -2141
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-01
• Decision Date: 2002-05-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840996174695	K021379	000
00840996174404	K021379	000
00840996163675	K021379	000
00840996163668	K021379	000
00840996122894	K021379	000
00840996122887	K021379	000
00840996122870	K021379	000
00840996122863	K021379	000
00840996122856	K021379	000