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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 8 of 15
DeviceModel / ReferenceRegistriesClassStatus
StarGraft Putty SGP200
FDA UDI
Class IIActive
OsseoGuard Flex OGF3040
FDA UDI
Class IIActive
OssiMend Bioactive Moldable MCCBA2025
FDA UDI
Class IIActive
RegenerOss Resorbable Xenograft ROXR20
FDA UDI
Class IIActive
PLENA Graft 1.0 PMC1010
FDA UDI
Class IIActive
EvoBone Plug EBP0625
FDA UDI
Class IIActive
naturesQue MaxOss P 58492
FDA UDI
Class IIActive
Mem-Lok Pliable PBLE-ML3040
FDA UDI
Class IIActive
DurAdapt DFCS11
FDA UDI
Class IIActive
PlatFORM BG 45-2525
FDA UDI
Class IIActive
MatrixMem CMPT1520
FDA UDI
Class IIUnknown
DuraMend-Onlay™ Plus NDMOP45
FDA UDI
Class IIActive
CollaShield Extend CSE15X20
FDA UDI
Class IIActive
RegenerOss Synthetic ROSBGP05
FDA UDI
Class IIActive
Augmatrix M630-100-10
FDA UDI
Class IIActive
TenoMend CTW6050
FDA UDI
Class IIActive
Stylos BA | Putty STYP020
FDA UDI
Class IIActive
contour BA CBA-400
FDA UDI
Class IIActive
Opus BA Putty 71410314
FDA UDI
Class IIActive
Socket Repair Membrane 0154
FDA UDI
Class IIActive
Plena Wound Dressing Tape BDDWDT2575
FDA UDI
UActive
Opus BA Putty 71410307
FDA UDI
Class IIActive
PlatFORM CM Putty CM68905
FDA UDI
Class IIActive
NeuroMatrix CNC4025
FDA UDI
Class IIActive
Straumann Membrane Flex 070.009
FDA UDI
Class IIActive
BiFORM Bioactive Moldable Matrix BFBA-4000
FDA UDI
Class IIActive
MaxxDerm+ XE152
FDA UDI
Class IIActive
BoneSync BioActive ABS-3400-20
FDA UDI
Class IIActive
AccuFuse WMP025
FDA UDI
Class IIActive
DuraMatrix-Onlay Plus DMOP11
FDA UDI
Class IIActive
BoneSync BioActive ABS-3500-05
FDA UDI
Class IIActive
Opus BA Strip 71420305
FDA UDI
Class IIActive
X-GEN Granules PMC2010
FDA UDI
Class IIActive
TenoWrap ABS-16050
FDA UDI
Class IIActive
BiFORM Bioactive Moldable BFBA-1000
FDA UDI
Class IIActive
DuraMatrix Suturable DMS45
FDA UDI
Class IIActive
MatrixFlex CDMPP1520
FDA UDI
Class IIActive
BoneSync BioActive ABS-3400-10
FDA UDI
Class IIActive
StarGraft Granules SGG200
FDA UDI
Class IIActive
Opus™ BA Putty 71410520
FDA UDI
Class IIActive
NeoGenix XP 64092
FDA UDI
Class IIActive
OssiMend Conformable Putty PS-MCCPC50
FDA UDI
Class IIActive
PlatFORM CM Pad CM78704
FDA UDI
Class IIActive
DuraMatrix-Onlay Conform DMOC22
FDA UDI
Class IIActive
Opus BA Putty 71410205
FDA UDI
Class IIActive
PlatFORM BG 45-2515
FDA UDI
Class IIActive
Stratofuse BA47-000002
FDA UDI
Class IIActive
RegenerOss Resorbable Xenograft ROXRLG10
FDA UDI
Class IIActive
Bio-Reign™ Bioactive BR-05
FDA UDI
Class IIActive
Opus™ BA Putty 71410205
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.