Stryker Resorbable Fixation System

Plate, Bone

Stryker Leibinger Micro Implants

The following data is part of a premarket notification filed by Stryker Leibinger Micro Implants with the FDA for Stryker Resorbable Fixation System.

Pre-market Notification Details

• Device ID: K213777
• 510k Number: K213777
• Device Name: Stryker Resorbable Fixation System
• Classification: Plate, Bone
• Applicant: Stryker Leibinger Micro Implants 750 Trade Centre Way -Suite 200 Portage, MI 49002
• Contact: Gregory Gohl
• Correspondent: Gregory Gohl; Stryker Leibinger Micro Implants 750 Trade Centre Way -Suite 200 Portage, MI 49002
• Product Code: JEY
• Subsequent Product Code: GXR
• Subsequent Product Code: HBW
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-03
• Decision Date: 2022-02-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04546540337177	K213777	000
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37613252477458	K213777	000