The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Masterloc Stem: Lateralized Plus.
Device ID | K173267 |
510k Number | K173267 |
Device Name: | MasterLoc Stem: Lateralized Plus |
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 | Elizabeth Rose Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504 |
Product Code | LZO |
Subsequent Product Code | KWY |
Subsequent Product Code | LPH |
Subsequent Product Code | LZY |
Subsequent Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-11 |
Decision Date | 2017-12-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630040715843 | K173267 | 000 |
07630040715836 | K173267 | 000 |
07630040715829 | K173267 | 000 |
07630040715812 | K173267 | 000 |
07630040715805 | K173267 | 000 |
07630040715799 | K173267 | 000 |
07630040715782 | K173267 | 000 |
07630040715775 | K173267 | 000 |
07630040715768 | K173267 | 000 |