BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

CORENTEC CO., LTD

The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox Id Stem, Bencox Metal Head, Bencox Bipolar Cup.

Pre-market Notification Details

• Device ID: K112019
• 510k Number: K112019
• Device Name: BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: CORENTEC CO., LTD 11TH CHUNGHO TOWER 748-1 BANPO 1 DONG Seocho Gu, Seoul, KR 137-040
• Contact: J.s. Daniel
• Correspondent: J.s. Daniel; CORENTEC CO., LTD 11TH CHUNGHO TOWER 748-1 BANPO 1 DONG Seocho Gu, Seoul, KR 137-040
• Product Code: KWY
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-14
• Decision Date: 2011-10-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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