PMA P140019S011

Device: i-FACTOR® Peptide Enhanced Bone Graft
Applicant: Cerapedics, LLC
PMA number: P140019
Supplement: S011
Product code: NOX
Decision date: 2024-09-13
Classification: Orthopedic
Generic name: Filler, bone void, synthetic peptide
Approval order statement: Approval for a change to the indications for use and labeling to include use of the product in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation.

Current openFDA PMA Record#

Device: i-FACTOR® Peptide Enhanced Bone Graft
Applicant: Cerapedics, LLC
PMA number: P140019
Supplement: S011
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2024-09-13
Decision code: APPR
Date received: 2024-06-14
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change to the indications for use and labeling to include use of the product in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation.