The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Delta Tt Acetabular System.
| Device ID | K141395 |
| 510k Number | K141395 |
| Device Name: | DELTA TT ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | LIMACORPORATE S.P.A. VIA NAZIONALE, 52 VILLANOVA DI SAN DANIELE Udine, IT 33038 |
| Contact | Stephen J Peoples |
| Correspondent | Stephen J Peoples LIMACORPORATE S.P.A. VIA NAZIONALE, 52 VILLANOVA DI SAN DANIELE Udine, IT 33038 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2014-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390085816 | K141395 | 000 |
| 08033390085809 | K141395 | 000 |
| 08033390085793 | K141395 | 000 |
| 08033390085786 | K141395 | 000 |
| 08033390085779 | K141395 | 000 |
| 08033390085762 | K141395 | 000 |