VEGA SPAN SPINOUS PROCESS PLATE SYSTEM

Appliance, Fixation, Spinal Interlaminal

SPINEFRONTIER, INC.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Vega Span Spinous Process Plate System.

Pre-market Notification Details

• Device ID: K102020
• 510k Number: K102020
• Device Name: VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly, MA 01915
• Contact: John Sullivan
• Correspondent: John Sullivan; SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly, MA 01915
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-19
• Decision Date: 2010-09-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190361000525	K102020	000
00190361000389	K102020	000
00190361000372	K102020	000
00190361000365	K102020	000
00190361000358	K102020	000
00190361000341	K102020	000
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00190361000297	K102020	000
00190361000396	K102020	000
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00190361000457	K102020	000
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00190361000006	K102020	000
00190361024644	K102020	000
00190361024637	K102020	000
00190361024620	K102020	000
00190361024613	K102020	000
00190361024606	K102020	000
00190361024590	K102020	000
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00190361000037	K102020	000
00190361000150	K102020	000
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00190361000266	K102020	000
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00190361000242	K102020	000
00190361000235	K102020	000
00190361000228	K102020	000
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00190361000204	K102020	000
00190361000198	K102020	000
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00190361000709	K102020	000
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00190361000686	K102020	000
00190361000679	K102020	000
00190361000532	K102020	000