Pisces Spinal System

Thoracolumbosacral Pedicle Screw System

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Pisces Spinal System.

Pre-market Notification Details

• Device ID: K203023
• 510k Number: K203023
• Device Name: Pisces Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020
• Contact: Divya Palan
• Correspondent: Darlene Hull; Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-10-02
• Decision Date: 2021-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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