ASCENT FLEXXBMC - The FG-002 Bone Marrow Concentrate (BMC) Device is a single-use, sterile concentrating device. It concentrates autologous bone marrow aspirate using a centrifuge.
2026-01-05
ORTHOASCENT LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3032542289 | 3032542289 | ORTHOASCENT LLC | 1 | N | 2026-01-01 | 9035 Wadsworth Pkwy Ste 1000 Westminster CO US 80021 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 331565 | 1632383780 | BK241083 |
| 331565 | 1852637123 |
GUDID#
ASCENT FLEXXPRP - The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.
2026-01-05
BMC Device Masterpack - The BMC Device Master Pack is a corrugated container that is composed of the following: 1 case of 8 FG-002 BMC Devices1 QA-LBL-004 BMC Device IFU8 FG-005 BMC Draw Kits8 FG-006 BMC Processing Kits
2026-01-05
ASCENT FLEXXBMC - The FG-002 Bone Marrow Concentrate (BMC) Device is a single-use, sterile concentrating device. It concentrates autologous bone marrow aspirate using a centrifuge.
2026-01-05
ASCENT FLEXXPRP - The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.
2026-01-05