Redi-Spine

Thoracolumbosacral Pedicle Screw System

Innovative Surgical Designs, Inc.

The following data is part of a premarket notification filed by Innovative Surgical Designs, Inc. with the FDA for Redi-spine.

Pre-market Notification Details

• Device ID: K181584
• 510k Number: K181584
• Device Name: Redi-Spine
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Innovative Surgical Designs, Inc. 3903 S. Walnut St. Bloomington, IN 47401
• Contact: Jon Rinehart
• Correspondent: Jon Rinehart; Innovative Surgical Designs, Inc. 3903 S. Walnut St. Bloomington, IN 47401
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-06-15
• Decision Date: 2018-08-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B50620593085351	K181584	000
B506L205933850651	K181584	000
B506L205933850751	K181584	000
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B50620593087351	K181584	000
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B506S205933851051	K181584	000
B506S205933851151	K181584	000
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B5061059309750TT1	K181584	000
B50610593204101	K181584	000
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B50610593206101	K181584	000
B5061059308750TT1	K181584	000
B5061059308745TT1	K181584	000
B506S205933851501	K181584	000
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B5061059308635TT1	K181584	000
B5061059308640TT1	K181584	000
B5061059308645TT1	K181584	000
B5061059308650TT1	K181584	000
B5061059308735TT1	K181584	000
B5061059308740TT1	K181584	000
B50610593207101	K181584	000