I-FACTOR PEPTIDE ENHANCED BONE GRAFT
FDA premarket approval P140019 · decided 2015-11-03
Approval details
- PMA number
- P140019
- Trade name
- I-FACTOR PEPTIDE ENHANCED BONE GRAFT
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, LLC
- Date received
- 2014-08-27
- Decision date
- 2015-11-03
- Days to decision
- 433 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- 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 R
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