PEDIPLATES

Plate, Fixation, Bone

ORTHOPEDIATRICS, CORP.

The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Pediplates.

Pre-market Notification Details

• Device ID: K090666
• 510k Number: K090666
• Device Name: PEDIPLATES
• Classification: Plate, Fixation, Bone
• 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: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: OBT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-13
• Decision Date: 2009-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841132108970	K090666	000
00841132113707	K090666	000
00841132113714	K090666	000
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00841132113967	K090666	000
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00841132123683	K090666	000