Data / Medical devices / United States / Allosource

Allosource: FDA-registered device maker in Centennial, CO, United States, 4 510(k) clearances

Name: Allosource FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Allosource is registered with the FDA (registration 3000215346) in Centennial, CO, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 27, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3000215346
Address: 6278 S Troy Circle, Centennial, CO, United States, 80111
Owner or operator: AlloSource (10025681)
Roles: Contract manufacturer, Manufacturer
First device listed: June 29, 2011
Registered through: 2026
Brand names listed: AceConnex Pre-Sutured Fascia, AlloFuse Gel, AlloFuse Plus Paste, AlloFuse Plus Putty, AlloFuse Putty, BiomaX Bone Graft Putty, BiomaX Bone Graft Putty Plus Chips, HERO DBM Gel and more

Devices it lists

Device	Product code	Class	Role	Source
Cuff, Nerve	JXI	2	Contract manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	MBP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Contract manufacturer	accessdata.fda.gov
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	OWW	2	Contract manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 27, 2023	K213046	AceConnex Pre-Sutured Fascia	GAT	Substantially Equivalent	Allosource	accessdata.fda.gov
March 20, 2018	K170957	ReConnex Pre-Sutured Tendon	GAT	Substantially Equivalent	Allosource	accessdata.fda.gov
January 10, 2011	K103036	ALLOFUSE PLUS	MQV	Substantially Equivalent	Allosource, Inc.	accessdata.fda.gov
December 4, 2008	K071849	ALLOFUSE GEL AND PUTTY	MQV	Substantially Equivalent	Allosource, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 25, 2014	67986	Class II	Terminated	AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed	The donor was hemodiluted.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.