Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K211701
Device Classification Name
More FDA Info for this Device
510(K) Number
K211701
Device Name
X-Guide« Surgical Navigation System
Applicant
X-Nav Technologies, LLC
1555 Bustard Road, Suite 75
Lansdale, PA 19446 US
Other 510(k) Applications for this Company
Contact
Kimberly Chan
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QRY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/03/2021
Decision Date
02/01/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact