The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox Mirabo Cup Bencox Mirabo Insert (standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug.
| Device ID | K120924 |
| 510k Number | K120924 |
| Device Name: | BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-27 |
| Decision Date | 2012-09-10 |
| Summary: | summary |