I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Filler, Bone Void, Synthetic Peptide

FDA Premarket Approval P140019

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the i-factor peptide enhanced bone graft. This combination product is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from c3-c4 to c6-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. I-factor peptide enhanced bone graft p-15 putty must be used inside an allograft bone ring and with supplemental anterior plate fixation.

• Device: I-FACTOR PEPTIDE ENHANCED BONE GRAFT
• Classification Name: Filler, Bone Void, Synthetic Peptide
• Generic Name: Filler, Bone Void, Synthetic Peptide
• Applicant: CERAPEDICS, LLC
• Date Received: 2014-08-27
• Decision Date: 2015-11-03
• Notice Date: 2015-11-30
• PMA: P140019
• Supplement: S
• Product Code: NOX
• Docket Number: 15M-4343
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: CERAPEDICS, LLC 11025 Dover Street suite 1600 westminster, CO 80021
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

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