I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Filler, Bone Void, Synthetic Peptide

FDA Premarket Approval P140019 S001

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

Approval of the protocol for the ode lead pma post-approval study.

DeviceI-FACTOR PEPTIDE ENHANCED BONE GRAFT
Classification NameFiller, Bone Void, Synthetic Peptide
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantCERAPEDICS, LLC
Date Received2015-12-03
Decision Date2016-03-17
PMAP140019
SupplementS001
Product CodeNOX
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product Yes
Applicant Address CERAPEDICS, LLC 11025 Dover Street suite 1600 westminster, CO 80021

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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