Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210542
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K210542
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Carlsmed, Inc.
4250 Executive Sq., Ste. 675
La Jolla, CA 92037 US
Other 510(k) Applications for this Company
Contact
Karen Liu
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/24/2021
Decision Date
06/30/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
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