The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalock All-suture Anchors.
Device ID | K193461 |
510k Number | K193461 |
Device Name: | MectaLock All-Suture Anchors |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
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 38118 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-16 |
Decision Date | 2020-02-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630971259140 | K193461 | 000 |
07630971259133 | K193461 | 000 |
07630971259126 | K193461 | 000 |
07630971259119 | K193461 | 000 |
07630971259102 | K193461 | 000 |
07630971259096 | K193461 | 000 |