The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Delta Tt Pro.
| Device ID | K182099 |
| 510k Number | K182099 |
| Device Name: | Delta TT Pro |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Limacorporate S.p.A. via Nazionale 52 Villanova Di San Daniele, IT 33038 |
| Contact | Roberto Gabetta |
| Correspondent | Roberto Gabetta Limacorporate S.p.A. via Nazionale 52 Villanova Di San Daniele, IT 33038 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2018-12-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DELTA TT PRO 87792578 not registered Dead/Abandoned |
LIMACORPORATE S.P.A. 2018-02-09 |