The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Amistem-p Short Neck.
Device ID | K192126 |
510k Number | K192126 |
Device Name: | AMIStem-P Short Neck |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
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 | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-06 |
Decision Date | 2019-11-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630971243828 | K192126 | 000 |
07630971243712 | K192126 | 000 |
07630971243705 | K192126 | 000 |
07630971243699 | K192126 | 000 |
07630971243682 | K192126 | 000 |
07630971243675 | K192126 | 000 |
07630971243668 | K192126 | 000 |
07630971243651 | K192126 | 000 |
07630971243644 | K192126 | 000 |
07630971243729 | K192126 | 000 |
07630971243736 | K192126 | 000 |
07630971243811 | K192126 | 000 |
07630971243804 | K192126 | 000 |
07630971243798 | K192126 | 000 |
07630971243781 | K192126 | 000 |
07630971243774 | K192126 | 000 |
07630971243767 | K192126 | 000 |
07630971243750 | K192126 | 000 |
07630971243743 | K192126 | 000 |
07630971243637 | K192126 | 000 |