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 |