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.
| Device | i-FACTOR® Peptide Enhanced Bone Graft |
| Generic Name | Filler, Bone Void, Synthetic Peptide |
| Applicant | CERAPEDICS, LLC11025 Dover Streetsuite 1600westminster, CO 80021 PMA NumberP140019 Supplement NumberS007 Date Received10/19/2022 Decision Date11/15/2022 Product Code NOX Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-19 |
| Decision Date | 2022-11-15 |
| PMA | P140019 |
| Supplement | S007 |
| Product Code | NOX |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | CERAPEDICS, LLC 11025 Dover Street suite 1600 westminster, CO 80021 PMA NumberP140019 Supplement NumberS007 Date Received10/19/2022 Decision Date11/15/2022 Product Code NOX Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement a Change To The Manufacturing Process For I-FACTOR® Bone Graft To Allow Blending Of Up To Four Batches Of P-15 Coated Anorganic Bone Mineral (ABM) |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00850001680028 | P140019 | 000 |
| M8517000101 | P140019 | 002 |
| 00850001680011 | P140019 | 002 |
| 00850001680004 | P140019 | 002 |