The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Limacorporate Kirschner Wire.
| Device ID | K203475 |
| 510k Number | K203475 |
| Device Name: | LimaCorporate Kirschner Wire |
| Classification | Pin, Fixation, Smooth |
| Applicant | Limacorporate S.p.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Contact | Ilaria Giannuzzi |
| Correspondent | Lacey Harbour Limacorporate S.p.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-25 |
| Decision Date | 2021-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390190183 | K203475 | 000 |
| 08033390190176 | K203475 | 000 |
| 08033390188494 | K203475 | 000 |