The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Delta Dual Mobility System.
| Device ID | K181491 |
| 510k Number | K181491 |
| Device Name: | Delta Dual Mobility System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Limacorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele, IT 33038 |
| Contact | Roberto Gabetta |
| Correspondent | Stephen Peoples Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | LZO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-06 |
| Decision Date | 2019-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390117722 | K181491 | 000 |
| 08033390020060 | K181491 | 000 |
| 08033390059763 | K181491 | 000 |
| 08033390059794 | K181491 | 000 |
| 08033390062183 | K181491 | 000 |
| 08033390062817 | K181491 | 000 |
| 08033390086325 | K181491 | 000 |
| 08033390086332 | K181491 | 000 |
| 08033390117692 | K181491 | 000 |
| 08033390117715 | K181491 | 000 |
| 08033390012447 | K181491 | 000 |