Daytona® Small Stature Growth Rod Conversion Set

Growing Rod System

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Daytona® Small Stature Growth Rod Conversion Set.

Pre-market Notification Details

• Device ID: K193224
• 510k Number: K193224
• Device Name: Daytona® Small Stature Growth Rod Conversion Set
• Classification: Growing Rod System
• Applicant: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008
• Contact: Jesse Albright
• Correspondent: Alicia Mcarthur; SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008
• Product Code: PGM
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-22
• Decision Date: 2020-02-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10889981212254	K193224	000
10889981185961	K193224	000
10889981152840	K193224	000
10889981152833	K193224	000
10889981152826	K193224	000
10889981152819	K193224	000
10889981152802	K193224	000
10889981152796	K193224	000