Bencox THR System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Corentec Co., Ltd.

The following data is part of a premarket notification filed by Corentec Co., Ltd. with the FDA for Bencox Thr System.

Pre-market Notification Details

• Device ID: K211866
• 510k Number: K211866
• Device Name: Bencox THR System
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, KR 31056
• Contact: Seungri Kim
• Correspondent: Sungwon Yang; Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, KR 31056
• Product Code: JWH
• Subsequent Product Code: KWY
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MBH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-16
• Decision Date: 2021-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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