Able Medical Devices Valkyrie Thoracic Fixation System

Plate, Fixation, Bone

JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices

The following data is part of a premarket notification filed by Jm Longyear Manufacturing, Llc D.b.a. Able Medical Devices with the FDA for Able Medical Devices Valkyrie Thoracic Fixation System.

Pre-market Notification Details

• Device ID: K202889
• 510k Number: K202889
• Device Name: Able Medical Devices Valkyrie Thoracic Fixation System
• Classification: Plate, Fixation, Bone
• Applicant: JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices 512 4th Street Gwinn, MI 49841
• Contact: Wade Depas
• Correspondent: Nathan Wright; Empirical Testing Corp 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-28
• Decision Date: 2021-03-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810071390234	K202889	000
00810071390005	K202889	000
00810071390616	K202889	000
00810071390609	K202889	000
00810071390593	K202889	000
00810071390630	K202889	000
00810071390623	K202889	000
00810071390586	K202889	000
00810071390579	K202889	000
00810071390562	K202889	000
00810071390555	K202889	000
00810071390548	K202889	000
00810071390531	K202889	000
00810071390012	K202889	000
00810071390029	K202889	000
00810071390036	K202889	000
00810071390227	K202889	000
00810071390241	K202889	000
00810071390203	K202889	000
00810071390197	K202889	000
00810071390180	K202889	000
00810071390173	K202889	000
00810071390166	K202889	000
00810071390159	K202889	000
00810071390074	K202889	000
00810071390067	K202889	000
00810071390050	K202889	000
00810071390043	K202889	000
00810071390524	K202889	000