SCS CLARIS SPINAL SCREWS, TYPES V,G,E

Orthosis, Spinal Pedicle Fixation

ORTHOTEC,LLC

The following data is part of a premarket notification filed by Orthotec,llc with the FDA for Scs Claris Spinal Screws, Types V,g,e.

Pre-market Notification Details

• Device ID: K011807
• 510k Number: K011807
• Device Name: SCS CLARIS SPINAL SCREWS, TYPES V,G,E
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: ORTHOTEC,LLC 8202 SHERMAN RD. Chesterland, OH 44026
• Contact: Karen E Warden
• Correspondent: Karen E Warden; ORTHOTEC,LLC 8202 SHERMAN RD. Chesterland, OH 44026
• 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: 2001-06-11
• Decision Date: 2001-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840996121576	K011807	000
00840996121743	K011807	000
00840996121750	K011807	000
00840996121767	K011807	000
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00840996121804	K011807	000
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00840996121828	K011807	000
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00840996121859	K011807	000
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00840996121729	K011807	000
00840996121712	K011807	000
00840996121583	K011807	000
00840996121590	K011807	000
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00840996122139	K011807	000
00840996122146	K011807	000
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00840996121989	K011807	000
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00840996122016	K011807	000
00840996122023	K011807	000
00840996122412	K011807	000