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 |