PMA P140019S013

Device: i-FACTOR® Peptide Enhanced Graft Substitute
Applicant: Cerapedics, LLC
PMA number: P140019
Supplement: S013
Product code: NOX
Decision date: 2026-04-07
Classification: Orthopedic
Generic name: Filler, bone void, synthetic peptide
Approval order statement: Change in the location for performance of the mass spectral analysis for the P-15 drug substance release specification from SGS North America (NAM), Inc, West Chester PA as a contract laboratory to Bachem Americas to being performed inhouse at Bachem Americas, Torrence, CA

Current openFDA PMA Record#

Device: i-FACTOR® Peptide Enhanced Graft Substitute
Applicant: Cerapedics, LLC
PMA number: P140019
Supplement: S013
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2026-04-07
Decision code: OK30
Date received: 2026-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the location for performance of the mass spectral analysis for the P-15 drug substance release specification from SGS North America (NAM), Inc, West Chester PA as a contract laboratory to Bachem Americas to being performed inhouse at Bachem Americas, Torrence, CA