Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K202528 |
Device Name |
Cannulated Power Driver Attachment |
Applicant |
K2M Inc. |
600 Hope Parkway SE |
Leesburg,
VA
20175
|
|
Applicant Contact |
Megan Callanan |
Correspondent |
K2M Inc. |
600 Hope Parkway SE |
Leesburg,
VA
20175
|
|
Correspondent Contact |
Megan Callanan |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 09/01/2020 |
Decision Date | 10/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|