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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 15 of 15

Device	Model / Reference	Registries	Class	Status
RejuvaKnee™ Collagen Meniscus Implant	K242302	FDA 510(k)	Class II	Active
Mineral Collagen Composite Bioactive Moldable	K182074	FDA 510(k)	Class II	Active
Collagen Dental Membrane - Conformable IIBP	K142496	FDA 510(k)	Class II	Active
Collagen Dental Wound Dressings	K152600	FDA 510(k)	U	Active
Collagen Topical Wound Dressing	K030921	FDA 510(k)	U	Active
Collagen Dural Regeneration Matrix	K150825	FDA 510(k)	Class II	Active
Collagen Dental Membrane Iii	K062846	FDA 510(k)	Class II	Active
Flexible Cooagen Nerve Cuff	K131541	FDA 510(k)	Class II	Active
Collagen Dental Membrane V	K100156	FDA 510(k)	Class II	Active
Soft Tissue Augmentation Resorbable Matrix	K233203	FDA 510(k)	Class II	Active
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix	K240424	FDA 510(k)	Class II	Active
Collagen Bone Healing Protective Sheet	K052041	FDA 510(k)	Class II	Active
Collagen Nerve Wrap	K060952	FDA 510(k)	Class II	Active
Collagen Dura Regeneration Membrane - Repair	K251191	FDA 510(k)	Class II	Active
Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix	K083742	FDA 510(k)	Class II	Active
Osteoguide Anorganic Bone Mineral Products	K043034	FDA 510(k)	Class II	Active
Collagen Dental Menbrane - Conformable Ii	K062881	FDA 510(k)	Class II	Active
Collagen Dental Membrane	K011695	FDA 510(k)	Class II	Active
Collagen Dental Mambrane - Porcine Type I Collagen	K110600	FDA 510(k)	Class II	Active
Porcine Anorganic Bone Mineral	K140714	FDA 510(k)	Class II	Active
Synoss Synthetic Bone Graft Material	K072397	FDA 510(k)	Class II	Active
Duramatrix Collagen Dura Substitute Membrane - Onlay And Suturable	K061487	FDA 510(k)	Class II	Active
Collagen Periodontal Membrane	K003339	FDA 510(k)	Class II	Active
Modification To: Collagen Topical Wound Dressing	K040211	FDA 510(k)	U	Active
Ossimend (tm) Bone Graft Material	K052812	FDA 510(k)	Class II	Active
Anorganic Bone Mineral with Collagen in Delivery Applicator	K171008	FDA 510(k)	Class II	Active
Porcine Anorganic Bone Mineral in Delivery Applicator	K162158	FDA 510(k)	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.