The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox Foret & Bencox Delta.
| Device ID | K121665 |
| 510k Number | K121665 |
| Device Name: | BENCOX FORET & BENCOX DELTA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-06 |
| Decision Date | 2012-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806373834509 | K121665 | 000 |
| 08806373834387 | K121665 | 000 |
| 08806373834264 | K121665 | 000 |
| 08806373834257 | K121665 | 000 |
| 08806373834240 | K121665 | 000 |
| 08806373834233 | K121665 | 000 |
| 08806373834226 | K121665 | 000 |
| 08806373834219 | K121665 | 000 |
| 08806373834202 | K121665 | 000 |
| 08806373834196 | K121665 | 000 |
| 08806373834394 | K121665 | 000 |
| 08806373834400 | K121665 | 000 |
| 08806373834493 | K121665 | 000 |
| 08806373834486 | K121665 | 000 |
| 08806373834479 | K121665 | 000 |
| 08806373834462 | K121665 | 000 |
| 08806373834455 | K121665 | 000 |
| 08806373834448 | K121665 | 000 |
| 08806373834431 | K121665 | 000 |
| 08806373834424 | K121665 | 000 |
| 08806373834417 | K121665 | 000 |
| 08806373834189 | K121665 | 000 |