Avanti Orthopaedics 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated Screws

Screw, Fixation, Bone

Avanti Orthopaedics, Inc.

The following data is part of a premarket notification filed by Avanti Orthopaedics, Inc. with the FDA for Avanti Orthopaedics 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated Screws.

Pre-market Notification Details

• Device ID: K222967
• 510k Number: K222967
• Device Name: Avanti Orthopaedics 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated Screws
• Classification: Screw, Fixation, Bone
• Applicant: Avanti Orthopaedics, Inc. 1814 Gilpin Avenue Wilmington, DE 19806
• Contact: J. Doug Patterson
• Correspondent: Linda Braddon; Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-09-27
• Decision Date: 2022-11-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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