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 4 of 15

Device	Model / Reference	Registries	Class	Status
BIA-GEN Bioactive	CS-MCCBA-100	FDA UDI	Class II	Active
contour BA	CBA-1600	FDA UDI	Class II	Active
MatrixOss Granules	PMC0510	FDA UDI	Class II	Active
DuraMatrix	CDSM33	FDA UDI	Class II	Active
SynOss Ridge	RAB2515	FDA UDI	Class II	Unknown
OSTEO-Flex	OSTEOF15x20	FDA UDI	Class II	Active
Symbios	32310006	FDA UDI	Class II	Active
TriOSS Bioactive Moldable	BA4025	FDA UDI	Class II	Active
Reguarde	3040	FDA UDI	Class II	Active
Plena Wound Dressing Foam	BDDWDF2040	FDA UDI	U	Active
OssiMend® Bioactive \| Putty	MCCBAM05	FDA UDI	Class II	Active
SMARTGRAFT Granules	0114.105	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-10	FDA UDI	Class II	Active
Reguarde	1520	FDA UDI	Class II	Active
AccuFuse	WMP025	FDA UDI	Class II	Active
MatrixOss Syringe	PMCS05	FDA UDI	Class II	Active
OsseoGuard	OG1520	FDA UDI	Class II	Active
NeoGenix XP	64095	FDA UDI	Class II	Active
MinerOss XP	MINXP-CAN4.0SM	FDA UDI	Class II	Active
naturesQue MaxOss P	58491	FDA UDI	Class II	Active
DuraMatrix-Onlay Plus	DMOP45	FDA UDI	Class II	Active
OssiGuide	PS-OG10	FDA UDI	Class II	Active
MatrixDerm Plug	BDDWDP1020	FDA UDI	U	Active
BVital GENOSS Granules	BS-G010	FDA UDI	Class II	Active
Stylos BA Strip	STYS005	FDA UDI	Class II	Active
PuraFLEX	YSSPF15	FDA UDI	Class II	Active
Profiniti Bioactive	AFBA020	FDA UDI	Class II	Active
OsseoGuard Flex	OGF2030	FDA UDI	Class II	Active
OssiMend® Bioactive \| Puck	MCCBA025	FDA UDI	Class II	Active
Stylos BA \| Strip	STYS005	FDA UDI	Class II	Active
X-GEN Syringe	PMCS025	FDA UDI	Class II	Active
OsteoPlug™	OGP1020	FDA UDI	Class II	Active
Opus Strip	71321210	FDA UDI	Class II	Active
Arthrex Nerve Wrap	ABS-4050W	FDA UDI	Class II	Active
RegenerOss Resorbable Xenograft	ROXR40	FDA UDI	Class II	Active
NeoGenix XP	64096	FDA UDI	Class II	Active
OSTEO-Foam	OSTEOFOAM	FDA UDI	U	Active
StarGraft Putty	SGP100	FDA UDI	Class II	Active
Opus Strip	71320620	FDA UDI	Class II	Active
Symbios	32310003	FDA UDI	Class II	Active
StarMem 4-6	SM1520	FDA UDI	Class II	Active
DuraMatrix Suturable	DMS11	FDA UDI	Class II	Active
Socket Repair Membrane	0154	FDA UDI	Class II	Active
OssiMend® Bioactive \| Puck	MCCBA05	FDA UDI	Class II	Active
BiFORM Bioactive Moldable Matrix	BFBA-2000	FDA UDI	Class II	Active
PuraPLUG	YSSPLG	FDA UDI	U	Active
Arthrex Nerve Conduit	ABS-5025C	FDA UDI	Class II	Active
OSTEO-Derm	OSTEOD20x30	FDA UDI	Class II	Active
MaxxDerm	XD152	FDA UDI	Class II	Active
Stratofuse	BA48-100010	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.