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510(k) Data Aggregation
K Number
K071555Device Name
FORTAGEN ORAL MEMBRANE
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2007-08-30
(84 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FortaGen Oral Membrane is intended to be used during guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier membrane for:
- Ridge augmentation for later implant insertions;
- . Simultaneous ridge augmentation and implant insertions;
- . Ridge augmentation around implants inserted in delayed extraction sites;
- . Ridge augmentation around implants inserted in immediate extraction sites;
- . Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
- Over the window in lateral window sinus elevation procedures; .
- . In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
- . In intra bony defects around teeth;
- . For treatment of recession defects, together with coronally positioned flap;
- . In furcation defects in multi-rooted teeth.
Device Description
FortaGen Oral Membrane consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied hydrated in sheet form in sizes ranging from 13 mm x 25 mm to 40 mm x 50 mm in sterile double layer peelable packaging.
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K Number
K051647Device Name
FORTADERM ANTIMICROBIAL WOUND DRESSING
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2005-11-08
(140 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDerm™ Antimicrobial PHMB Wound Dressing may be used for the management of: 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, 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
FortaDerm™ Antimicrobial PHMB Wound Dressing consists of two layers, crosslinked sheet of fenestrated sheet of porcine intestinal collagen coated with 0.1 % Polyhexamethylene Biguanide hydrochloride (PHMB). FortaDerm Wound Dressing is supplied dry in sheet form in sizes ranging from 4 x 4 cm to 12 x 36 cm. The device is packaged in sterile, sealed single pouches.
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K Number
K042809Device Name
CUFFPATCH
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2004-11-02
(21 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CuffPatch™ surgical mesh is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.
CuffPatch™ surgical mesh 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. CuffPatch™ surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Device Description
CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix is primarily Type I porcine collagen, and is free of cells and cell remnants. The product is supplied sterile in doublelayered peelable packaging.
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K Number
K021107Device Name
FORTAFLEX SURGICAL SLING
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2002-05-15
(40 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FortaPerm™ is intended for implantation to reinforce and support soft tissue where weakness exists including, but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, FortaPerm may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.
Device Description
Forta Perm consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 2 x 5 cm to 12 x 36 cm in sterile double laye packaging.
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K Number
K021105Device Name
FORTAFLEX SURGICAL MESH
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2002-05-10
(35 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
Device Description
FortaGen consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.
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K Number
K020049Device Name
FORTAFLEX SURGICAL MESH
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2002-03-18
(70 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FortaFlex™ Surgical Mesh is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or sutere anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.
Device Description
FortaFlex Surgical Mesh consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.
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K Number
K011025Device Name
FORTAFLEX SURGICAL MESH
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2001-08-24
(141 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011026Device Name
FORTADERM WOUND DRESSING
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2001-06-13
(70 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011027Device Name
FORTAFLEX SURGICAL SLING
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
2001-05-30
(55 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970561Device Name
GRAFT PATCH
Manufacturer
ORGANOGENESIS, INC.
Date Cleared
1997-08-01
(169 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORGANOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
Device Description
GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, e.g., hernia repairs. The device is composed of heat-laminated layers of crosslinked porcine collagen. GraftPatch® is similar in design, materials, function, and intended use to other surgical meshes which are currently in U.S. commercial distribution.
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