i-FACTOR™ Peptide Enhanced Bone Graft

FDA Premarket Approval P140019 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

A change in the type of biological indicators (bi) used in annual sterilization revalidation

Devicei-FACTOR™ Peptide Enhanced Bone Graft
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantCERAPEDICS, LLC
Date Received2021-12-09
Decision Date2022-01-07
PMAP140019
SupplementS005
Product CodeNOX 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address CERAPEDICS, LLC 11025 Dover Street suite 1600 westminster, CO 80021

Supplemental Filings

Supplement NumberDateSupplement Type
P140019Original Filing
S005 2021-12-09 30-day Notice
S004 2020-06-15 Normal 180 Day Track No User Fee
S003 2019-04-17 Normal 180 Day Track No User Fee
S002 2016-01-19 Normal 180 Day Track
S001 2015-12-03 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00850001680028 P140019 000
M8517000101 P140019 002
00850001680011 P140019 002
00850001680004 P140019 002

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