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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceI-FACTOR PEPTIDE ENHANCED BONE GRAFT
Classification Namefiller, bone void, synthetic peptide
Generic Namefiller, bone void, synthetic peptide
Applicant
CERAPEDICS, LLC
11025 dover street
suite 1600
westminster, CO 80021
PMA NumberP140019
Date Received08/27/2014
Decision Date11/03/2015
Product Code
NOX[ Registered Establishments with NOX ]
Docket Number 15M-4343
Notice Date 11/30/2015
Advisory Committee Orthopedic
Clinical Trials NCT00310440
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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