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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 5 of 15

Device	Model / Reference	Registries	Class	Status
DuraMend-Onlay™ Plus	NDMOP22	FDA UDI	Class II	Active
O-Fuse Diamond Matrix	OSSMCCBA2012	FDA UDI	Class II	Active
BiFORM Bioactive Moldable	BFBA-2000	FDA UDI	Class II	Active
Stylos BA \| Putty	STYP005	FDA UDI	Class II	Active
PlatFORM CM Strip	CM46405	FDA UDI	Class II	Active
PlatFORM CM Strip	CM46420	FDA UDI	Class II	Active
MaxxCote	XCOTE	FDA UDI	U	Active
NeoGen Tape	64060	FDA UDI	U	Active
NeuroFlex	CNCF4025	FDA UDI	Class II	Active
OssiMend Putty	MCCP10	FDA UDI	Class II	Active
Opus™ BA Strip	71420610	FDA UDI	Class II	Active
Straumann SocketPlug	070.052	FDA UDI	Class II	Active
TriOSS Bioactive Moldable	BA1006	FDA UDI	Class II	Active
CopiOs Extend	0191Z	FDA UDI	Class II	Active
Salvin Fulfill	FULFILL-6x25-PKG-5	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3400-05	FDA UDI	Class II	Active
DurAdapt	DFCS33	FDA UDI	Class II	Active
Symbios	32310003	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA-400	FDA UDI	Class II	Active
BioCORE	214-0060-BK	FDA UDI	Class II	Active
Straumann Membrane Flex	070.008	FDA UDI	Class II	Active
OssiMend Conformable Putty	MCCPC50	FDA UDI	Class II	Active
Augmatrix	M620-020-10	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-20	FDA UDI	Class II	Active
BIA-GEN Bioactive	CS-MCCBA025	FDA UDI	Class II	Active
Plena Flex	CDMPP2030	FDA UDI	Class II	Active
PlatFORM CM Pad	CM78710	FDA UDI	Class II	Active
Regenafill	RFP10X20	FDA UDI	Class II	Active
TBS Bone Plug	TBSRGN11-CS	FDA UDI	Class II	Active
NeoGenix XP	64094	FDA UDI	Class II	Active
StarGraft Granules	SGG050	FDA UDI	Class II	Active
Opus Putty	71310314	FDA UDI	Class II	Active
OssiMend Putty	MCCP10	FDA UDI	Class II	Active
Collagen Plug	0102Z	FDA UDI	U	Active
Symbios	32310008	FDA UDI	Class II	Unknown
CollaShield	CS30x40	FDA UDI	Class II	Active
BioMend	0107Z	FDA UDI	Class II	Active
Neogen Collagen Flex L	64052	FDA UDI	Class II	Active
VENADO Carbonate Apatite Putty	4817-T0005	FDA UDI	Class II	Active
Symbios	32310005	FDA UDI	Class II	Active
OssiMend	MCC2050	FDA UDI	Class II	Active
Neogen Collagen Firm S	64055	FDA UDI	Class II	Active
PLENA Graft 0.5cc Syringe	PMCS05	FDA UDI	Class II	Active
OsseoGuard Flex	OGF2030	FDA UDI	Class II	Active
VENADO Carbonate Apatite Block	4817-T64051	FDA UDI	Class II	Active
OssiMend Putty	MCCP02	FDA UDI	Class II	Active
naturesQue ColTect P	58498	FDA UDI	Class II	Active
Nivis	FCWD15	FDA UDI	U	Active
NeoGenix XP	64093	FDA UDI	Class II	Active
PlatFORM BG	45-2125	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.