The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Ligament Staple.
| Device ID | K210456 |
| 510k Number | K210456 |
| Device Name: | Ligament Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 83118 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971258594 | K210456 | 000 |
| 07630345719133 | K210456 | 000 |