Is this your brand? Sign in to claim ownership.

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 6 of 15

Device	Model / Reference	Registries	Class	Status
Opus BA Putty	71410102	FDA UDI	Class II	Active
Opus™ BA Putty	71410310	FDA UDI	Class II	Active
VENADO Carbonate Apatite Strip	4817-T121051	FDA UDI	Class II	Active
OSTEO-Plug	OSTEOPLUG	FDA UDI	U	Active
BIA-GEN Bioactive	CS-MCCBA-200	FDA UDI	Class II	Active
OssiMend Conformable Putty	MCCPC25	FDA UDI	Class II	Active
Zimmer Collagen Patch	0101Z	FDA UDI	U	Active
DuraMend-Onlay™ Plus	NDMOP57	FDA UDI	Class II	Active
BiFORM Bioactive Moldable Matrix	BFBA-1000	FDA UDI	Class II	Active
MaxxPlug	XPLUG	FDA UDI	U	Active
Stylos BA Putty	STYP010	FDA UDI	Class II	Active
O-Fuse Diamond Matrix	OSSMCCBA0503	FDA UDI	Class II	Active
Plena Medium	PDM1520	FDA UDI	Class II	Active
OssiMend® Bioactive \| Strip	MCCBA1006	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-20	FDA UDI	Class II	Active
BiFORM Bioactive Moldable	BFBA-4000	FDA UDI	Class II	Active
BiFORM Bioactive Moldable	BFBA-0250	FDA UDI	Class II	Active
contour BA	CBA-500	FDA UDI	Class II	Active
DuraMend-Onlay™	NDMO11	FDA UDI	Class II	Active
OssiMend® Bioactive	MCCBA4025	FDA UDI	Class II	Active
MinerOss XP	MINXP-CAN0.5SM	FDA UDI	Class II	Active
MaxxMem+	XP203	FDA UDI	Class II	Active
Plena Flex	CDMPP1520	FDA UDI	Class II	Active
AccuFuse	WMP20	FDA UDI	Class II	Active
MaxxDerm	XD203	FDA UDI	Class II	Active
ABIL Conformable Putty	A0507-01	FDA UDI	Class II	Active
Stylos BA Strip	STYS020	FDA UDI	Class II	Active
contour BA	CBA-800	FDA UDI	Class II	Active
naturesQue MaxOss P	58488	FDA UDI	Class II	Active
VENADO Carbonate Apatite Strip	4817-T122202	FDA UDI	Class II	Active
X-GEN Granules	PMC4010	FDA UDI	Class II	Active
Augmatrix	M620-050-10	FDA UDI	Class II	Active
Aptofuse	00010503	FDA UDI	Class II	Active
Profiniti Bioactive	AFBA050	FDA UDI	Class II	Active
RejuvaKnee	REJ075	FDA UDI	Class II	Active
BioMend Extend	0142Z	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA-050	FDA UDI	Class II	Active
Augmatrix	M610-050-10	FDA UDI	Class II	Active
PlatFORM CM Strip	CM46410	FDA UDI	Class II	Active
DuraMatrix	CDSM22	FDA UDI	Class II	Active
NeoGen Collagen Flex	64050	FDA UDI	Class II	Active
O-Fuse Diamond Matrix	OSSMCCBA1006	FDA UDI	Class II	Active
AccuFuse	WMP10	FDA UDI	Class II	Active
VIA Mend Bioactive Strip	VMB0010	FDA UDI	Class II	Active
Straumann Membrane Flex	070.010	FDA UDI	Class II	Active
VENADO Carbonate Apatite Putty	4817-T0002	FDA UDI	Class II	Active
Opus BA Strip	71422540	FDA UDI	Class II	Active
Opus BA Putty	71410520	FDA UDI	Class II	Active
NeuroMend	CNW12050	FDA UDI	Class II	Active
EvoBone Plug	EBP1020	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.