FDA.reportPublic FDA data

PMA P110008S004

Device
coflex Interlaminar Technology
Applicant
Companion Spine France
PMA number
P110008
Supplement
S004
Product code
NQO
Decision date
2016-02-09
Classification
Prosthesis, Spinous Process Spacer/plate
Generic name
Prosthesis, spinous process spacer/plate
Approval order statement
Addition of a second supplier for the instruments with the following part numbers: UAT00008, UAT00010, UAT00012, UAT00014, UAT00016, UBT10008, UBT10010, UBT10012, UBT10014, UBT10016, UAT10100, UAT10200, UAT10300, UAT20100, and UAT20110.

Current openFDA PMA Record#

Device
coflex Interlaminar Technology
Applicant
Companion Spine France
PMA number
P110008
Supplement
S004
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2016-02-09
Decision code
OK30
Date received
2016-01-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a second supplier for the instruments with the following part numbers: UAT00008, UAT00010, UAT00012, UAT00014, UAT00016, UBT10008, UBT10010, UBT10012, UBT10014, UBT10016, UAT10100, UAT10200, UAT10300, UAT20100, and UAT20110.