ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

Pin, Fixation, Smooth

ORTHOPEDIATRICS, CORP.

The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Pediflex Flexible Nail System.

Pre-market Notification Details

• Device ID: K082375
• 510k Number: K082375
• Device Name: ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
• Classification: Pin, Fixation, Smooth
• Applicant: ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw, IN 46580
• Contact: Gary Barnett
• Correspondent: Gary Barnett; ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw, IN 46580
• Product Code: HTY
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-18
• Decision Date: 2008-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841132119716	K082375	000
00841132119549	K082375	000
00841132119556	K082375	000
00841132119563	K082375	000
00841132119570	K082375	000
00841132119587	K082375	000
00841132119662	K082375	000
00841132119679	K082375	000
00841132119686	K082375	000
00841132119693	K082375	000
00841132119709	K082375	000
00841132119532	K082375	000