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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 13 of 15

Device	Model / Reference	Registries	Class	Status
OssiMend	MCC2020	FDA UDI	Class II	Active
Opus BA Putty	71410310	FDA UDI	Class II	Active
RegenerOss Resorbable Xenograft Syringe	ROXRS025	FDA UDI	Class II	Active
Neomem	N2030	FDA UDI	Class II	Active
PuraFLEX	YSSPF20	FDA UDI	Class II	Active
KBIO® Dura	KBI-DU 02 02-S	EUDAMEDFDA UDI	Class II	Active
UniFuze™ BA	805-0005	FDA UDI	Class II	Active
TBS Bone Plug	TBSRGN10-CS	FDA UDI	Class II	Active
Stylos BA \| Putty	STYP010	FDA UDI	Class II	Active
Stylos BA \| Strip	STYS010	FDA UDI	Class II	Active
BVital GENOSS Syringe	BS-GS0025	FDA UDI	Class II	Active
BioMend Extend	0140Z	FDA UDI	Class II	Active
Arthrex Nerve Wrap	ABS-12025W	FDA UDI	Class II	Active
NeoGen Foam	64061	FDA UDI	U	Active
X-Flex	CDMPP2030	FDA UDI	Class II	Active
Stratofuse	BA48-000010	FDA UDI	Class II	Active
Opus Putty	71310307	FDA UDI	Class II	Active
OssiMend BLOCK	MCCB10	FDA UDI	Class II	Active
Symbios	32310006	FDA UDI	Class II	Active
Heliogen	XP-1000	FDA UDI	U	Active
MatrixDerm EXT	PDMX2030	FDA UDI	Class II	Active
TenoMend	CTW16050	FDA UDI	Class II	Active
Symbios	32310007	FDA UDI	Class II	Active
CollaFill	CFP10	FDA UDI	U	Active
Neogen Collagen Firm L	64057	FDA UDI	Class II	Active
Nivis	FCWD20	FDA UDI	U	Active
Stylos BA Putty	STYP020	FDA UDI	Class II	Active
DuraMatrix-Onlay Plus	DMOP22	FDA UDI	Class II	Active
PARASORB RESODONT Flex	RDC1520	FDA UDI	Class II	Active
TenoWrap	ABS-16025	FDA UDI	Class II	Active
OSTEO-Derm Enhanced	OSTEODE20x30	FDA UDI	Class II	Active
Aptofuse	00011006	FDA UDI	Class II	Active
BiFORM Bioactive Moldable	BFBA-0500	FDA UDI	Class II	Active
NeuroMend	CNW4050	EUDAMEDFDA UDI	Class II	Active
BiFORM Bioactive Moldable Matrix	BFBA-0500	FDA UDI	Class II	Active
Amplifi	AMPLIFI-15X20	FDA UDI	Class II	Active
Heliogen	XP-2000	FDA UDI	U	Active
Collagen Patch	0101Z	FDA UDI	U	Active
OssiMend® Bioactive	MCCBA05	FDA UDI	Class II	Active
X-Flex	CDMPP3040	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-40	FDA UDI	Class II	Active
CopiOs Extend	0192Z	FDA UDI	Class II	Active
DuraMend™	NDM45	FDA UDI	Class II	Active
BoneSync BioActive	ABS-3500-05	FDA UDI	Class II	Active
AccuFuse	WMP20	FDA UDI	Class II	Active
Opus™ BA Putty	71410307	FDA UDI	Class II	Active
MatrixOss Granules	PMC1020	FDA UDI	Class II	Active
Zimmer Collagen Plug	0102Z	FDA UDI	U	Active
X-GEN Granules	PMC0510	FDA UDI	Class II	Active
Plena Plug	SMCP0625	FDA UDI	Class II	Active

Related Companies

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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.