SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)

Plate, Fixation, Bone

SYNTHES USA

The following data is part of a premarket notification filed by Synthes Usa with the FDA for Synthes Variable Angle Lcp Elbow System (medical And Posterolateral Distal Humerus Plates).

Pre-market Notification Details

• Device ID: K120717
• 510k Number: K120717
• Device Name: SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380
• Contact: Angela F Lassandro
• Correspondent: Angela F Lassandro; SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-08
• Decision Date: 2012-05-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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H679041173030	K120717	000
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