PMA P050039S011

Device: EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
Applicant: Exactech, Inc.
PMA number: P050039
Supplement: S011
Product code: MRA
Decision date: 2012-09-27
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: ADDITION OF LASER MARKING SYSTEMS FOR PURPOSES OF THE PRODUCT IDENTIFICATION OF THE MATING FEMORAL STEMS USED WITH THE DEVICES.

Current openFDA PMA Record#

Device: EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
Applicant: Exactech, Inc.
PMA number: P050039
Supplement: S011
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2012-09-27
Decision code: OK30
Date received: 2012-08-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF LASER MARKING SYSTEMS FOR PURPOSES OF THE PRODUCT IDENTIFICATION OF THE MATING FEMORAL STEMS USED WITH THE DEVICES.