ORTHOASCENT LLC

Matched from indexed company URL: 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.

ORTHOASCENT, LLC

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.

ORTHOASCENT, LLC

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.

ORTHOASCENT, LLC

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.

ORTHOASCENT, LLC

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 Devices 1 QA-LBL-004 BMC Device IFU 8 FG-005 BMC Draw Kits 8 FG-006 BMC Processing Kits

ORTHOASCENT, LLC

2026-01-05