The following data is part of a premarket notification filed by Medacta International with the FDA for Masterloc Stem.
Device ID | K160289 |
510k Number | K160289 |
Device Name: | MasterLoc Stem |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | MEDACTA INTERNATIONAL STRADA REGINA Castel San Pietro, CH Ch 6874 |
Contact | Michael G. Loiterman |
Correspondent | Roshana Ahmed 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 | 2016-02-03 |
Decision Date | 2016-05-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630030885631 | K160289 | 000 |
07630030885624 | K160289 | 000 |
07630030885525 | K160289 | 000 |
07630030885518 | K160289 | 000 |
07630030861284 | K160289 | 000 |
07630030861260 | K160289 | 000 |