STRYKER RESORBABLE FIXATION SYSTEM

Plate, Fixation, Bone

Stryker

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

Pre-market Notification Details

• Device ID: K113109
• 510k Number: K113109
• Device Name: STRYKER RESORBABLE FIXATION SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: Stryker 750 TRADE CENTER WAY STE 200 Porage, MI 49002
• Contact: Manish Patel
• Correspondent: Manish Patel; Stryker 750 TRADE CENTER WAY STE 200 Porage, MI 49002
• Product Code: HRS
• Subsequent Product Code: DZJ
• Subsequent Product Code: EZX
• Subsequent Product Code: HWC
• Subsequent Product Code: MAI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-20
• Decision Date: 2011-12-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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