PMA P860005
- Device
- PRO OSTEON 500 BONE GRAFT SUBSTITUTE
- Applicant
- Interpore Intl.
- PMA number
- P860005
- Supplement
- S012
- Product code
- MBS
- Decision date
- 2002-05-31
- Generic name
- Filler, bone void, non-osteoinduction
- Approval order statement
- APPROVAL TO REPLACE STATIC COMPRESSION TESTING WITH ULTIMATE COMPRESSION TESTING DURING THE MANUFACTURING PROCESS FOLLOWING DEPYROGENATION.
Current openFDA PMA Record#
- Device
- PRO OSTEON 500 BONE GRAFT SUBSTITUTE
- Applicant
- Interpore Intl.
- PMA number
- P860005
- Supplement
- S012
- Product code
- MBS
- Generic name
- Filler, bone void, non-osteoinduction
- Decision date
- 2002-05-31
- Decision code
- APPR
- Date received
- 2001-12-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO REPLACE STATIC COMPRESSION TESTING WITH ULTIMATE COMPRESSION TESTING DURING THE MANUFACTURING PROCESS FOLLOWING DEPYROGENATION.