TRUE SPINAL FUSSION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

INNOVATIVE SURGICAL DESIGNS

The following data is part of a premarket notification filed by Innovative Surgical Designs with the FDA for True Spinal Fussion System.

Pre-market Notification Details

• Device ID: K133690
• 510k Number: K133690
• Device Name: TRUE SPINAL FUSSION SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 Bloomington, IN 47401
• Contact: Ed Morris
• Correspondent: Ed Morris; INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 Bloomington, IN 47401
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-02
• Decision Date: 2014-05-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B50610593051	K133690	000
B5061059309A901	K133690	000
B5061059318CL1	K133690	000
B5061059318CP1	K133690	000
B5061059318MI1	K133690	000
B5061059318SL1	K133690	000
B5061059318SP1	K133690	000
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