Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K190892 |
Device Name |
MectaScrew PEEK Interference Screw |
Applicant |
Medacta International SA |
Strada Regina |
Castel San Pietro,
CH
CH-6874
|
|
Applicant Contact |
Stefano Baj |
Correspondent |
Medacta USA |
3973 Delp Street |
Memphis,
TN
38118
|
|
Correspondent Contact |
Chris Lussier |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 04/05/2019 |
Decision Date | 06/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|