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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 2 of 15

Device	Model / Reference	Registries	Class	Status
Profiniti Bioactive	AFMS010	FDA UDI	Class II	Active
NeoGen Collagen Flex	64052	FDA UDI	Class II	Active
OsseoGuard	OG2030	FDA UDI	Class II	Active
Cohealyx™	BDCDM1010	FDA UDI	U	Active
OsseoGuard Flex	OGF1520	FDA UDI	Class II	Active
NeoGen Collagen Firm	64056	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-10	FDA UDI	Class II	Active
VIA Mend Putty	VMP0050	FDA UDI	Class II	Active
AccuFuse	WMP10	FDA UDI	Class II	Active
NeuroFlex	CNCF2025	FDA UDI	Class II	Active
RegenerOss Resorbable Xenograft Syringe	ROXRS05	FDA UDI	Class II	Active
OssiMend BLOCK	MCCB20	FDA UDI	Class II	Active
DuraMatrix Onlay	CDSLM11	FDA UDI	Class II	Active
contour BA	CBA-200	FDA UDI	Class II	Active
MinerOss XP Syringe	MINXP-SYR0.5	FDA UDI	Class II	Active
NeuroMatrix	CNC2025	FDA UDI	Class II	Active
CollaShield	CS20x30	FDA UDI	Class II	Active
DuraMatrix	CDSM13	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA05	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-10	FDA UDI	Class II	Active
AccuFuse	WMP05	FDA UDI	Class II	Active
SMARTGRAFT Syringe	0114.451	FDA UDI	Class II	Active
OssiMend	MCC2020-1	FDA UDI	Class II	Active
Augmatrix	M600-040-10	FDA UDI	Class II	Active
Symbios	32310001	FDA UDI	Class II	Active
DurAdapt	DFCS22	FDA UDI	Class II	Active
Cohealyx™	BDCDM1020	FDA UDI	U	Active
OssiMend Putty	MCCP02	FDA UDI	Class II	Active
OssiMend® Bioactive	MCCBA1006	FDA UDI	Class II	Active
PlatFORM CM Strip	CM46420	FDA UDI	Class II	Active
OssiMend BLOCK	MCCB2004	FDA UDI	Class II	Active
PlatFORM CM Strip	CM46405	FDA UDI	Class II	Active
NeuroFlex	CNCF6025	FDA UDI	Class II	Active
Symbios	32310004	FDA UDI	Class II	Active
TenoMend	CTW12050	FDA UDI	Class II	Active
Gibson Healthcare® Bone Graft Plug	5824-404	FDA UDI	Class II	Active
OssiMend	MCC2050	FDA UDI	Class II	Active
PlatFORM CM Block	CM25510	FDA UDI	Class II	Active
MatrixMem	CMPT1520	FDA UDI	Class II	Active
Profiniti	AFP05	FDA UDI	Class II	Active
naturesQue ColTect P	58497	FDA UDI	Class II	Active
ABIL Putty	A0506-02	FDA UDI	Class II	Active
MatrixOss Granules	PMC4010	FDA UDI	Class II	Active
MinerOss XP Syringe	MINXP-SYR1.0	FDA UDI	Class II	Unknown
OssiMend Putty	MCCP05	FDA UDI	Class II	Active
Opus BA Strip	71421220	FDA UDI	Class II	Active
DuraMend-Onlay™ Plus	NDMOP11	FDA UDI	Class II	Active
Cohealyx™	BDCDM2035	FDA UDI	U	Active
Symbios	32310001	FDA UDI	Class II	Active
Opus™ BA Putty	71410102	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.