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. |
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Device | I-FACTOR PEPTIDE ENHANCED BONE GRAFT |
Generic Name | Filler, bone void, synthetic peptide |
Applicant | CERAPEDICS, LLC 11025 DOVER STREET SUITE 1600 WESTMINSTER, CO 80021 |
PMA Number | P140019 |
Date Received | 08/27/2014 |
Decision Date | 11/03/2015 |
Product Code |
NOX |
Docket Number | 15M-4343 |
Notice Date | 11/30/2015 |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00310440
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Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
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