OrthoButton AL

Fastener, Fixation, Nondegradable, Soft Tissue

Riverpoint Medical

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Orthobutton Al.

Pre-market Notification Details

• Device ID: K171060
• 510k Number: K171060
• Device Name: OrthoButton AL
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: Riverpoint Medical 825 NE 25TH Avenue Portland, OR 97232
• Contact: Nathan Cook
• Correspondent: Nathan Cook; Riverpoint Medical 825 NE 25TH Avenue Portland, OR 97232
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-10
• Decision Date: 2017-06-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842962105160	K171060	000