Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000215346

FEI Number

3000215346

Entity Name

ALLOSOURCE

City/State/Country

Centennial, CO, US

Establishment Address

6278 S Troy Circle, Centennial, CO 80111, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AlloSource (Owner Number: 10025681)

Owner / Operator Contact Address

6278 South Troy Circle, Centennial, CO 80111, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AlloFuse Plus Paste HERO DBM Plus Putty HERO DBM Plus Paste AlloFuse Plus Putty StimuBlast CB Paste StimuBlast CB Putty BiomaX Bone Graft Putty Plus Chips AlloFuse Gel HERO DBM Putty StimuBlast Putty AlloFuse Putty HERO DBM Gel StimuBlast Gel BiomaX Bone Graft Putty ReConnex Pre-Sutured Tendon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2011-06-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2011-06-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2011-06-29
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2011-06-29
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2017-12-19
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2023-12-11
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2022-07-15
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2020-12-14
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2018-07-03
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2021-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AlloSource

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000215346. Last updated year: 2026. Please use registration number 3000215346 when referencing this establishment in official correspondence.