The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Mobilit Cup.
| Device ID | K191831 |
| 510k Number | K191831 |
| Device Name: | MobiliT Cup |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
| Contact | Severine Siracusa |
| Correspondent | Severine Siracusa Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-09 |
| Decision Date | 2020-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056139236419 | K191831 | 000 |
| 05056139209482 | K191831 | 000 |
| 05056139209499 | K191831 | 000 |
| 05056139209512 | K191831 | 000 |
| 05056139209536 | K191831 | 000 |
| 05056139209550 | K191831 | 000 |
| 05056139209567 | K191831 | 000 |
| 05056139209574 | K191831 | 000 |
| 05056139223099 | K191831 | 000 |
| 05056139223143 | K191831 | 000 |
| 05056139223167 | K191831 | 000 |
| 05056139223174 | K191831 | 000 |
| 05056139223181 | K191831 | 000 |
| 05056139223204 | K191831 | 000 |
| 05056139223235 | K191831 | 000 |
| 05056139223259 | K191831 | 000 |
| 05056139223266 | K191831 | 000 |
| 05056139209468 | K191831 | 000 |