i-FACTOR Peptide Enhanced Bone Graft

FDA Premarket Approval P140019 S004

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 for updated labeling to include the results from the completed 72-month follow-up post-approval study.

• Device: i-FACTOR Peptide Enhanced Bone Graft
• Generic Name: Filler, Bone Void, Synthetic Peptide
• Applicant: CERAPEDICS, LLC
• Date Received: 2020-06-15
• Decision Date: 2020-07-22
• PMA: P140019
• Supplement: S004
• Product Code: NOX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Pas
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: CERAPEDICS, LLC 11025 Dover Street suite 1600 westminster, CO 80021

Supplemental Filings

Supplement Number	Date	Supplement Type
P140019		Original 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 ID	PMA	Supp
00850001680028	P140019	000
M8517000101	P140019	002
00850001680011	P140019	002
00850001680004	P140019	002