The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Bone Screws Dia. 5,0 Mm.
| Device ID | K210717 |
| 510k Number | K210717 |
| Device Name: | Bone Screws Dia. 5,0 Mm |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | LimaCorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Antonia Trevisan |
| Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, TX 76006 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-10 |
| Decision Date | 2021-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390197021 | K210717 | 000 |
| 08033390196840 | K210717 | 000 |
| 08033390196857 | K210717 | 000 |
| 08033390196871 | K210717 | 000 |
| 08033390196888 | K210717 | 000 |
| 08033390196895 | K210717 | 000 |
| 08033390196901 | K210717 | 000 |
| 08033390196925 | K210717 | 000 |
| 08033390196932 | K210717 | 000 |
| 08033390196949 | K210717 | 000 |
| 08033390196956 | K210717 | 000 |
| 08033390196963 | K210717 | 000 |
| 08033390196970 | K210717 | 000 |
| 08033390196987 | K210717 | 000 |
| 08033390196994 | K210717 | 000 |
| 08033390197007 | K210717 | 000 |
| 08033390197014 | K210717 | 000 |
| 08033390196796 | K210717 | 000 |