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Found 46 results
510(k) Data Aggregation
K Number
K243071Device Name
Bovine Dermis Collagen Dermal Matrix
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-12-19
(83 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bovine Dermis Collagen Dermal Matrix is indicated for the management of wounds, including:
- . Full thickness and Partial thickness wounds
- . Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
- . Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- . Trauma wounds (abrasions, lacerations, and skin tears)
- Draining wounds
- Partial thickness burns
Device Description
Bovine Dermis Collagen Dermal Matrix is an absorbent, porous, collagen matrix engineered from purified collagen derived from bovine dermal tissue. Bovine Dermal Matrix should be applied directly to the wound, covering the entire wound surface.
Bovine Dermis Collagen Dermal Matrix is supplied sterile, non-pyrogenic and for single use only.
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K Number
K242302Device Name
RejuvaKnee Collagen Meniscus Implant
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-10-02
(58 days)
Product Code
OLC
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.
Device Description
The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue.
RejuvaKnee is supplied sterile and is intended for single use.
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K Number
K233203Device Name
Soft Tissue Augmentation Resorbable Matrix
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-05-01
(216 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.
STAR Matrix is indicated for:
- Covering of implants placed in immediate or delayed extraction sockets;
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
Device Description
The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.
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K Number
K240424Device Name
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-03-12
(28 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Device Description
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorqanic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
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K Number
K231942Device Name
Mineral Collagen Composite Bioactive Extra Moldable
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2023-08-02
(33 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mineral Collagen Composite Bioactive Extra Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
Device Description
Mineral Collagen Composite Bioactive Extra Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteroconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. The purified type I collagen is derived from bovine Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
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K Number
K221735Device Name
Mineral Collagen Composite Bioactive Moldable
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2022-12-20
(188 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
Device Description
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.
The product is available in various sizes and is provided sterile, non-pvrogenic, and for single use only.
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K Number
K213341Device Name
Fibrillar Collagen Wound Dressing
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2022-05-31
(236 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as:
- Pressure ulcers
- Venous stasis ulcers
- Diabetic ulcers
- Acute wounds, for example trauma and surgical wounds
- Partial-thickness burns
Device Description
The Fibrillar Collagen Wound Dressing is an absorbent microfibrillar collagen matrix intended for the management of moderately to heavily exudating wounds and the control of minor bleeding. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The Fibrillar Collagen Wound Dressing is applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the product, being comprised of microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
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K Number
K202183Device Name
Porcine Mineral Collagen Composite
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2021-04-02
(241 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.
Porcine Mineral Collagen Composite is indicated for:
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of infrabony periodontal defects .
- Filling of defects after root resection, apicoectomy, and cystectomy .
- . Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration (GBR).
Device Description
Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.
The product is available in the following shape and sizes:
| Product Shape | Dimensions |
|---------------|--------------------------------------------|
| Plug | 10mm (5mm dry) x 17mm (diameter x length) |
| Umbrella | 17mm (13mm dry) x 10mm (diameter x height) |
| Umbrella | 22mm (17mm dry) x 12mm (diameter x height) |
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K Number
K201859Device Name
Porcine Mineral Collagen Composite Moldable
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2020-09-11
(67 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Porcine Mineral Collagen Composite Moldable is indicated for:
- · Augmentation or reconstructive treatment of alveolar ridge
- · Filling of infrabony periodontal defects
- · Filling of defects after root resection, apicoectomy, and cystectomy
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of maxillary sinus floor
- · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Device Description
Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.
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K Number
K182074Device Name
Mineral Collagen Composite Bioactive Moldable
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2019-03-21
(232 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Collagen Matrix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
Device Description
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
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