The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Bone Screws 6.5mm.
| Device ID | K172456 |
| 510k Number | K172456 |
| Device Name: | Bone Screws 6.5mm |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | LimaCorporate S.p.A. Via Nazionale, 52 33038 Villanova Di San Daniele Udine, IT |
| Contact | Michela Zanotto |
| Correspondent | Stephen J. Peoples LimaCorporate S.p.A. Via Nazionale, 52 33038 Villanova Di San Daniele Udine, IT |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBF |
| Subsequent Product Code | MBL |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390123013 | K172456 | 000 |
| 08033390123006 | K172456 | 000 |
| 08033390122993 | K172456 | 000 |
| 08033390122986 | K172456 | 000 |
| 08033390122979 | K172456 | 000 |
| 08033390122962 | K172456 | 000 |
| 08033390110693 | K172456 | 000 |