PMA P140019S012

Device: i-FACTOR™ Peptide Enhanced Bone Graft
Applicant: Cerapedics, LLC
PMA number: P140019
Supplement: S012
Product code: NOX
Decision date: 2025-02-06
Classification: Orthopedic
Generic name: Filler, bone void, synthetic peptide
Approval order statement: Change to the sterilization equipment to add a second ARS steam sterilizer (referred to in this submission as “Sterilizer 2”) at the existing manufacturing facility

Current openFDA PMA Record#

Device: i-FACTOR™ Peptide Enhanced Bone Graft
Applicant: Cerapedics, LLC
PMA number: P140019
Supplement: S012
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2025-02-06
Decision code: OK30
Date received: 2025-01-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the sterilization equipment to add a second ARS steam sterilizer (referred to in this submission as “Sterilizer 2”) at the existing manufacturing facility