Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Applications Submitted by Gui Pires
FDA 510(k) Number
Submission Date
Device Name
Applicant
K242414
08/14/2024
TiLink-P Joint Fusion System
SurGenTec LLC
K240086
01/11/2024
Ion 3D
SurGenTec, LLC
K240664
03/08/2024
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
SurGenTec, LLC
K240720
03/15/2024
TiLink-P SI Joint Fusion System
SurGenTec, LLC
K243945
12/20/2024
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
SurGenTec LLC
K243949
12/23/2024
OsteoFlo HydroFiber
SurGenTec, LLC
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact