The following data is part of a premarket notification filed by Medacta International Sa with the FDA for 3dmetal Tibial Cones.
Device ID | K170149 |
510k Number | K170149 |
Device Name: | 3DMetal Tibial Cones |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
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 | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-17 |
Decision Date | 2017-08-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630030884146 | K170149 | 000 |
07630030884061 | K170149 | 000 |
07630030884078 | K170149 | 000 |
07630030884085 | K170149 | 000 |
07630030884092 | K170149 | 000 |
07630030884108 | K170149 | 000 |
07630030884115 | K170149 | 000 |
07630030884122 | K170149 | 000 |
07630030884139 | K170149 | 000 |
07630030884054 | K170149 | 000 |