The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Masterlock Extension.
Device ID | K191145 |
510k Number | K191145 |
Device Name: | MasterLock Extension |
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 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-30 |
Decision Date | 2019-05-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630040731430 | K191145 | 000 |
07630040731423 | K191145 | 000 |
07630040731393 | K191145 | 000 |
07630040731386 | K191145 | 000 |