The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalif Anterior Stand Alone Extension.
Device ID | K183426 |
510k Number | K183426 |
Device Name: | MectaLIF Anterior Stand Alone Extension |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
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 | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-11 |
Decision Date | 2019-03-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630040727983 | K183426 | 000 |
07630040727846 | K183426 | 000 |
07630040727853 | K183426 | 000 |
07630040727860 | K183426 | 000 |
07630040727877 | K183426 | 000 |
07630040727884 | K183426 | 000 |
07630040727891 | K183426 | 000 |
07630040727907 | K183426 | 000 |
07630040727914 | K183426 | 000 |
07630040727921 | K183426 | 000 |
07630040727938 | K183426 | 000 |
07630040727945 | K183426 | 000 |
07630040727952 | K183426 | 000 |
07630040727969 | K183426 | 000 |
07630040727976 | K183426 | 000 |
07630040727839 | K183426 | 000 |