Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K233542 |
Device Name |
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System |
Applicant |
Stryker Leibinger GmbH & Co. KG |
Bötzinger Straße 41 |
Freiburg Baden-Wurttemberg,
DE
D-79111
|
|
Applicant Contact |
Megan B Guilbault |
Correspondent |
Stryker Leibinger GmbH & Co. KG |
Bötzinger Straße 41 |
Freiburg Baden-Wurttemberg,
DE
D-79111
|
|
Correspondent Contact |
Megan B Guilbault |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/03/2023 |
Decision Date | 03/14/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|