Avanti Distal Radius And Forearm System

Plate, Fixation, Bone

Avanti Orthopaedics, Inc.

The following data is part of a premarket notification filed by Avanti Orthopaedics, Inc. with the FDA for Avanti Distal Radius And Forearm System.

Pre-market Notification Details

• Device ID: K191118
• 510k Number: K191118
• Device Name: Avanti Distal Radius And Forearm System
• Classification: Plate, Fixation, Bone
• Applicant: Avanti Orthopaedics, Inc. 4606 Simon Road Wilmington, DE 19803
• Contact: J. Doug Patterson
• Correspondent: Linda Braddon; Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-26
• Decision Date: 2019-12-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810054090656	K191118	000
00810054090489	K191118	000
00810054090472	K191118	000
00810054090465	K191118	000
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00810054090618	K191118	000
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00810054090571	K191118	000
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00810054090540	K191118	000
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00810054090519	K191118	000
00810054090342	K191118	000
00810054090335	K191118	000
00810054090328	K191118	000
00810054090151	K191118	000
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00810054090120	K191118	000
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00810054090090	K191118	000
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00810054090069	K191118	000
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00810054090045	K191118	000
00810054090038	K191118	000
00810054090021	K191118	000
00810054090168	K191118	000
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00810054090311	K191118	000
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00810054090298	K191118	000
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00810054090250	K191118	000
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00810054090205	K191118	000
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00810054090014	K191118	000
00810054090663	K191118	000
00810054091264	K191118	000
00810054091141	K191118	000
00810054091134	K191118	000
00810054091127	K191118	000
00810054091110	K191118	000
00810054091103	K191118	000
00810054091097	K191118	000
00810054091080	K191118	000
00810054091073	K191118	000
00810054091066	K191118	000
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00810054091035	K191118	000
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00810054091011	K191118	000
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00810054091240	K191118	000
00810054091271	K191118	000
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00810054091233	K191118	000
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00810054091202	K191118	000
00810054091196	K191118	000
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00810054090991	K191118	000
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00810054090793	K191118	000
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00810054090700	K191118	000
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00810054090847	K191118	000
00810054090670	K191118	000