PMA P160050S007

Device
Barricaid® Annular Closure Device
Applicant
Intrinsic Therapeutics
PMA number
P160050
Supplement
S007
Product code
QES
Decision date
2023-08-25
Classification
Orthopedic
Generic name
Reherniation reduction device
Approval order statement
Modification of grip material for the grit blasting step of the Ti64 bone anchor.

Current openFDA PMA Record#

Device
Barricaid® Annular Closure Device
Applicant
Intrinsic Therapeutics
PMA number
P160050
Supplement
S007
Product code
QES
Generic name
Reherniation reduction device
Decision date
2023-08-25
Decision code
OK30
Date received
2023-08-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification of grip material for the grit blasting step of the Ti64 bone anchor.