The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Coren Total Hip System.
| Device ID | K103431 |
| 510k Number | K103431 |
| Device Name: | COREN TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | CORENTEC CO., LTD 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas CORENTEC CO., LTD 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-23 |
| Decision Date | 2011-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806373830778 | K103431 | 000 |
| 08806373830600 | K103431 | 000 |
| 08806373830617 | K103431 | 000 |
| 08806373830624 | K103431 | 000 |
| 08806373830631 | K103431 | 000 |
| 08806373830648 | K103431 | 000 |
| 08806373830655 | K103431 | 000 |
| 08806373830662 | K103431 | 000 |
| 08806373830679 | K103431 | 000 |
| 08806373830686 | K103431 | 000 |
| 08806373830693 | K103431 | 000 |
| 08806373830709 | K103431 | 000 |
| 08806373830716 | K103431 | 000 |
| 08806373830723 | K103431 | 000 |
| 08806373830730 | K103431 | 000 |
| 08806373830747 | K103431 | 000 |
| 08806373830761 | K103431 | 000 |
| 08806373830594 | K103431 | 000 |