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COLLAGEN MATRIX, INC.

United States·US-MF-000015783

Last updated September 17, 2026

Information

Country: United States
Address: 15 Thornton Rd, Oakland, United States
Website: collagenmatrix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (877) 540-3258
PRRC Contact: Peggy Hansen
EUDAMED SRN: US-MF-000015783
FDA FEI Number: 3008817245
DUNS Number: 176262442

Catalogue (727)

Page 10 of 15

Device	Model / Reference	Registries	Class	Status
Augmatrix	M610-100-10	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA-140	FDA UDI	Class II	Active
DuraMend-Onlay™	NDMO22	FDA UDI	Class II	Active
Collagen Tape	0100Z	FDA UDI	U	Active
OssiMend® Bioactive \| Putty	MCCBAM10	FDA UDI	Class II	Active
Mem-Lok Pliable	PBLE-ML2030	FDA UDI	Class II	Active
MaxxMem+	XP152	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA4025	FDA UDI	Class II	Active
SMARTGRAFT Granules	0114.103	FDA UDI	Class II	Active
Stratofuse	BA48-000020	FDA UDI	Class II	Active
TriOSS Bioactive Moldable	BA2012	FDA UDI	Class II	Active
MinerOss XP	MINXP-CAN1.0LG	FDA UDI	Class II	Active
Amplifi	AMPLIFI-30X40	FDA UDI	Class II	Active
SMARTGRAFT Granules	0114.102	FDA UDI	Class II	Active
OssiMend BLOCK	PS-MCCB10	FDA UDI	Class II	Active
NeoGen Collagen Firm	64057	FDA UDI	Class II	Active
OssiMend Bioactive Moldable	MCCBA2012	FDA UDI	Class II	Active
RejuvaKnee	REJ090	FDA UDI	Class II	Active
DuraMend Suturable	NDMS33	FDA UDI	Class II	Active
Nivis	FCWD10	FDA UDI	U	Active
OssiMend Bioactive Moldable	MCCBA0506	FDA UDI	Class II	Active
CollaShield Extend	CSE30X40	FDA UDI	Class II	Active
neoplug	neoplug	FDA UDI	U	Active
Stylos BA Putty	STYP002	FDA UDI	Class II	Active
Nivis	FCWD05	FDA UDI	U	Active
BoneSync BioActive	ABS-3500-40	FDA UDI	Class II	Active
PuraEXTEND	YSSPE20	FDA UDI	Class II	Active
MinerOss XP	MINXP-CAN2.0LG	FDA UDI	Class II	Active
BioMend Extend	0141Z	FDA UDI	Class II	Active
StarDerm 9-12	SD3040	FDA UDI	Class II	Active
PuraKOTE	YSSKTE	FDA UDI	U	Active
MaxxDerm+	XE203	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-20	FDA UDI	Class II	Active
SMARTGRAFT Syringe	0114.450	FDA UDI	Class II	Active
RegenerOss Resorbable Xenograft	ROXRLG20	FDA UDI	Class II	Active
SynOss Plug	SMCP1020	FDA UDI	Class II	Active
naturesQue MaxOss P	58494	FDA UDI	Class II	Active
Plena Wound Dressing Plug	BDDWDP1020	FDA UDI	U	Active
Opus™ BA Strip	71420305	FDA UDI	Class II	Active
Symbios	32310007	FDA UDI	Class II	Active
MaxxMem	XC203	FDA UDI	Class II	Active
DuraMend™	NDM22	FDA UDI	Class II	Active
RegenerOss	RGP1020	FDA UDI	Class II	Active
Opus Strip	71320610	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-05	FDA UDI	Class II	Active
VENADO Carbonate Apatite Putty	4817-T0010	FDA UDI	Class II	Active
Arthrex Nerve Conduit	ABS-4025C	FDA UDI	Class II	Active
Neomem FlexPlus	NF3040	FDA UDI	Class II	Active
Opus BA Strip	71420610	FDA UDI	Class II	Active
ASYN Puck	JABB00050	FDA UDI	Class II	Active

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FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 3, 2022	Z-1777-2022	—	open, classified	The packaging may not be sealed, which could compromise sterility.
Dec 13, 2021	Z-0668-2022	—	terminated	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Dec 13, 2021	Z-0669-2022	—	terminated	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Nov 5, 2019	Z-0909-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0910-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0908-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0907-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0912-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Nov 5, 2019	Z-0911-2020	—	terminated	The products may have been packaged with an incorrect Instructions for Use.
Mar 19, 2019	Z-1389-2019	—	terminated	Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Oct 30, 2018	Z-0752-2019	—	terminated	There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Aug 16, 2018	Z-0414-2019	—	terminated	There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Nov 17, 2015	Z-1173-2016	—	terminated	The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
Aug 25, 2015	Z-1096-2016	—	terminated	On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.
May 13, 2013	Z-1097-2016	—	terminated	During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.