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510(k) Data Aggregation
K Number
K173572Device Name
DSM Biomedical Calcium Phosphate Cement with Microspheres
Manufacturer
Kensey Nash Corporation dba DSM Biomedical
Date Cleared
2018-05-09
(170 days)
Product Code
MQV, MOV, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Kensey Nash Corporation dba DSM Biomedical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the sketal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process.
Device Description
DSM Biomedical Calcium Phosphate Cement with Microspheres is an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement with Microspheres is composed of calcium phosphate which converts to hydroxyapatite in vivo, bovine collagen powder, and PLGA microspheres. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement with Microspheres is supplied sterile by gamma irradiation and is non-pyrogenic.
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K Number
K173362Device Name
DSM Biomedical Calcium Phosphate Cement
Manufacturer
Kensey Nash Corporation dba DSM Biomedical
Date Cleared
2018-04-03
(159 days)
Product Code
MQV, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Kensey Nash Corporation dba DSM Biomedical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The DSM Biomedical Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The DSM Biomedical Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.
Device Description
DSM Biomedical Calcium Phosphate Cement as an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement is composed of calcium phosphate which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.
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K Number
K170245Device Name
DSM Biomedical Dental Bone Graft
Manufacturer
Kensey Nash Corporation dba DSM Biomedical
Date Cleared
2017-05-16
(110 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Kensey Nash Corporation dba DSM Biomedical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DSM Biomedical Dental Bone Graft is indicated for:
- Augmentation or reconstructive treatment of the 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 the 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
The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.
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K Number
K160474Device Name
DSM Biomedical Porcine Pericardium Dental Membrane
Manufacturer
Kensey Nash Corporation dba DSM Biomedical
Date Cleared
2016-06-07
(109 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Kensey Nash Corporation dba DSM Biomedical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants
- augmentation around implants placed in immediate extraction sockets
- augmentation around implants placed in delayed extraction sockets
- localized ridge augmentation for later implantation
- alveolar ridge reconstruction for prosthetic treatment
- filling of bone defects after root resection, cystectomy, removal of retained teeth
- guided bone regeneration in dehiscence defects
- guided tissue regeneration procedures in periodontal defects.
Device Description
The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.
The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.
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K Number
K141738Device Name
MEDEOR MATRIX WOUND DRESSING
Manufacturer
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
Date Cleared
2015-02-17
(235 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medeor Matrix Wound Dressing is indicated for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.
Medeor Matrix Wound Dressing is intended for one time use.
Device Description
Medeor Matrix Wound Dressing, Acellular Dermal Matrix is a resorbable porcine dermisderived dressing intended for the management of topical wounds. The device is sterilized by electron beam irradiation and supplied hydrated in a double layer package. The device is a prescription device for single use only.
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K Number
K133169Device Name
MESO TENDON MATRIX
Manufacturer
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
Date Cleared
2013-12-20
(64 days)
Product Code
OWY
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. Meso Tendon Matrix is supplied sterile and for one time use.
Device Description
Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
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K Number
K132025Device Name
MESO BILAYER SURGICAL MESH
Manufacturer
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
Date Cleared
2013-10-30
(121 days)
Product Code
FTM, OXH
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.) Meso Bilayer Surgical Mesh is supplied sterile and for one time use.
Device Description
Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
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K Number
K121310Device Name
MESOTHELIUM DENTAL MEMBRANE
Manufacturer
KENSEY NASH CORPORATION
Date Cleared
2013-07-11
(436 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
KENSEY NASH CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mesothelium Dental Membrane is indicated for: simultaneous use of GBR-membrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
The device is intended for one time use.
Device Description
Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.
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K Number
K112888Device Name
MESO WOUND MATRIX
Manufacturer
KENSEY NASH CORPORATION
Date Cleared
2012-02-10
(133 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KENSEY NASH CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.
The device is intended for one time use.
Device Description
Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.
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K Number
K094061Device Name
KENSEY NASH ECM SURGICAL PATCH
Manufacturer
KENSEY NASH CORPORATION
Date Cleared
2010-05-18
(138 days)
Product Code
FTM, OXE, OXH, PAG, PAJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
KENSEY NASH CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.
The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.
Device Description
The Kensey Nash ECM Surgical Patch is a resorbable porcine-peritoneum-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer packages. The product is packaged dry (lyophilized) to be hydrated prior to use.
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