← Back to catalogue

I-Factor Peptide Enhanced Bone Graft P-15 Putty

FDA PMA

Class III (US FDA PMA)

PMA P140019

by Cerapedics, LLC

Identity

Trade Name
I-FACTOR PEPTIDE ENHANCED BONE GRAFT FDA PMA
Generic Name
Filler, bone void, synthetic peptide FDA PMA

Identifiers

PMA Number
P140019 FDA PMA
FDA Product Code
NOX FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Orthopedic FDA PMA
FDA Decision
APPR Approved FDA PMA

The I-Factor Peptide Enhanced Bone Graft P-15 Putty is a synthetic peptide filler classified as a bone void filler (generic name: Filler, bone void, synthetic peptide). It is designed as a combination product for use within an allograft bone ring during anterior cervical spine reconstruction, aiding in the stabilization of degenerated cervical discs at single levels (C3–C4 to C6–C7) following discectomy for radiculopathy or myelopathy.

This device is supplied as a single-use, non-sterile putty intended for intraoperative preparation. It requires supplemental anterior plate fixation and must be used in conjunction with an allograft bone ring. Approved under FDA PMA (P140019), it is regulated as a Class III device under the NOX product code. Sterilization occurs via gamma irradiation prior to packaging, and storage follows manufacturer guidelines to maintain integrity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: i-FACTOR | Cerapedics Corporate, Homepage | Cerapedics Corporate, PDF I-FACTOR PEPTIDE ENHANCED BONE GRAFT - Food and Drug Administration, Cerapedics' i-FACTOR P-15 Peptide Enhanced Bone Graft, a Trusted Choice ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cerapedics, LLC

Sources (1)

  • FDA PMA P140019 24 fields · synced Sep 18, 2026