i-FACTOR® Peptide Enhanced Bone Graft

FDA Premarket Approval P140019 S007

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

Devicei-FACTOR® Peptide Enhanced Bone Graft
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantCERAPEDICS, LLC11025 Dover Streetsuite 1600westminster, CO 80021 PMA NumberP140019 Supplement NumberS007 Date Received10/19/2022 Decision Date11/15/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-19
Decision Date2022-11-15
PMAP140019
SupplementS007
Product CodeNOX 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressCERAPEDICS, LLC
11025 Dover Street
suite 1600
westminster, CO 80021 PMA NumberP140019 Supplement NumberS007 Date Received10/19/2022 Decision Date11/15/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
a Change To The Manufacturing Process For I-FACTOR® Bone Graft To Allow Blending Of Up To Four Batches Of P-15 Coated Anorganic Bone Mineral (ABM)

Supplemental Filings

Supplement NumberDateSupplement Type
P140019Original Filing
S007 2022-10-19 30-day Notice
S006 2022-01-19 30-day Notice
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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