The following data is part of a premarket notification filed by Corin Ltd. with the FDA for Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ Plus Acetabular Shell, Metafix™ Hip System, Trifit™ Cf And Ts Hip Systems, Taperfit™ Hip System, Revival™ Modular Hip System, Minihip™, Trinity™ Dual Mobility, Mobilit, Bipolar-i, Omni Mod.
| Device ID | K201657 |
| 510k Number | K201657 |
| Device Name: | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF And TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Corin Ltd. 480 Paramount Drive Raynham, MA 02767 |
| Contact | Christina Rovaldi |
| Correspondent | Robert A Poggie BioVera Inc. 65 Promenade Saint-Louis Notre-dame-de-l’ile-perrot, CA J7v 7p2 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-18 |
| Decision Date | 2021-07-28 |