Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K182000
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K182000
Device Name
Neurological Stereotaxic Instrument
Applicant
Globus Medical Inc.
2560 General Armistead Avenue
Audubon, PA 19403 US
Other 510(k) Applications for this Company
Contact
Kelly J. Baker
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/26/2018
Decision Date
01/29/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact