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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
LinkedIn
—
Facebook
—
Phone
(877) 540-3258
PRRC Contact
Peggy Hansen
EUDAMED SRN
US-MF-000015783
FDA FEI Number
3008817245
DUNS Number
176262442

Catalogue (727)

Page 9 of 15
DeviceModel / ReferenceRegistriesClassStatus
DuraMend-Onlay™ Plus NDMOP33
FDA UDI
Class IIActive
Stratofuse BA48-000005
FDA UDI
Class IIActive
Amplifi AMPLIFI-20X30
FDA UDI
Class IIActive
OssiMend Bioactive Moldable MCCBA0503
FDA UDI
Class IIActive
Symbios 32310004
FDA UDI
Class IIActive
Zimmer Collagen Patch 0101Z
FDA UDI
UActive
MatrixOss Granules PMC2010
FDA UDI
Class IIActive
DuraMatrix Onlay CDSLM57
FDA UDI
Class IIActive
OssiMend® Bioactive | Strip MCCBA4025
FDA UDI
Class IIActive
MatrixMem CMPT2030
FDA UDI
Class IIUnknown
OssiMend Bioactive Moldable MCCBA1012
FDA UDI
Class IIActive
PLENA Graft 1.0 PMC1010
FDA UDI
Class IIActive
Stratofuse BA47-000020
FDA UDI
Class IIActive
Augmatrix M630-200-10
FDA UDI
Class IIActive
DuraMatrix CDSM45
FDA UDI
Class IIActive
RegenerOss Resorbable Xenograft ROXR05
FDA UDI
Class IIActive
PlatFORM CM Strip CM46410
FDA UDI
Class IIActive
MatrixOss Granules PMC2020
FDA UDI
Class IIActive
Collatene DWDG0010
FDA UDI
UActive
DuraMatrix CDSM11
FDA UDI
Class IIActive
OssiMend PS-MCC2050
FDA UDI
Class IIActive
Neogen Collagen Flex M 64051
FDA UDI
Class IIActive
OssiMend® Bioactive MCCBA2012
FDA UDI
Class IIActive
MatrixMem CMPT2030
FDA UDI
Class IIActive
OssiMend PS-MCC2020
FDA UDI
Class IIActive
OssiMend® Bioactive | Putty MCCBAM20
FDA UDI
Class IIActive
TriOSS Bioactive Moldable BA1012
FDA UDI
Class IIActive
ABIL Putty A0506-01
FDA UDI
Class IIActive
Neomem FlexPlus NF1520
FDA UDI
Class IIActive
RegenerOss Synthetic ROSBGP20
FDA UDI
Class IIActive
MinerOss XP MINXP-CAN1.0SM
FDA UDI
Class IIActive
NeoGenix XP 64091
FDA UDI
Class IIActive
SMARTGRAFT Granules 0114.101
FDA UDI
Class IIActive
DuraMatrix Suturable DMS13
FDA UDI
Class IIActive
Gibson Healthcare® Bone Graft Plug 5824-413
FDA UDI
Class IIActive
Heliogen XP-0500
FDA UDI
UActive
OssiMend Block MCCB10
FDA UDI
Class IIActive
BVital GENOSS Granules BS-G005
FDA UDI
Class IIActive
BiFORM Bioactive Moldable Matrix BFBA-0250
FDA UDI
Class IIActive
MatrixDerm EXT PDMX1520
FDA UDI
Class IIActive
NeuroMatrix CNC3025
FDA UDI
Class IIActive
NeuroMatrix CNC2525
FDA UDI
Class IIActive
Regenafill RFP6X25
FDA UDI
Class IIActive
DurAdapt DFCS13
FDA UDI
Class IIActive
DuraMatrix-Onlay Conform DMOC33
FDA UDI
Class IIActive
TBS Bone Plug TBSRGN10
FDA UDI
Class IIActive
KBIO® Dura KBI-DU 03 03-S
FDA UDI
Class IIActive
naturesQue ColAid B 58499
FDA UDI
UActive
OssiMend Conformable Putty PS-MCCPC25
FDA UDI
Class IIActive
KBIO® Dura KBI-DU 01 01-S
FDA UDI
Class IIActive

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.

DateRecall No.ClassStatusReason
Aug 3, 2022Z-1777-2022—open, classified

The packaging may not be sealed, which could compromise sterility.

Dec 13, 2021Z-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, 2021Z-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, 2019Z-0909-2020—terminated

The products may have been packaged with an incorrect Instructions for Use.

Nov 5, 2019Z-0910-2020—terminated

The products may have been packaged with an incorrect Instructions for Use.

Nov 5, 2019Z-0908-2020—terminated

The products may have been packaged with an incorrect Instructions for Use.

Nov 5, 2019Z-0907-2020—terminated

The products may have been packaged with an incorrect Instructions for Use.

Nov 5, 2019Z-0912-2020—terminated

The products may have been packaged with an incorrect Instructions for Use.

Nov 5, 2019Z-0911-2020—terminated

The products may have been packaged with an incorrect Instructions for Use.

Mar 19, 2019Z-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, 2018Z-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, 2018Z-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, 2015Z-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, 2015Z-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, 2013Z-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.