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Found 5 results
510(k) Data Aggregation
K Number
K090288Device Name
ORTHADAPT PR
Manufacturer
PEGASUS BIOLOGICS, INC.
Date Cleared
2009-05-05
(89 days)
Product Code
FTL, FTM, OWX, OXA, OXD
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OrthADAPT® PR 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, hernias. suture-line reinforcement and other reconstructive procedures.
The device is also 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.
OrthADAPT® PR 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.
Device Description
OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.
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K Number
K071425Device Name
UNITE BIOMATRIX
Manufacturer
PEGASUS BIOLOGICS, INC.
Date Cleared
2007-06-20
(28 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PEGASUS BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers, ◆
- Venous ulcers, .
- . Chronic vascular ulcers,
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), ●
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
Device Description
The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
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K Number
K071065Device Name
ORTHADAPT BIOIMPLANT
Manufacturer
PEGASUS BIOLOGICS, INC.
Date Cleared
2007-05-04
(18 days)
Product Code
FTM, OWY, OXB, OXE
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OrthADAPT® Bioimplant (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, hernias, suture-line reinforcement, and other reconstructive procedures.
The device is also 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.
OrthADAPT® 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,
OrthADAPT® is intended for one-time use only.
Device Description
The OrthADAPT Bioimplant is a decellularized, equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
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K Number
K061494Device Name
DERMADAPT WOUND DRESSING
Manufacturer
PEGASUS BIOLOGICS, INC.
Date Cleared
2006-09-21
(113 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PEGASUS BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- . Draining wounds,
- Pressure sores/ulcers, ●
- Venous ulcers, .
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), .
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
Device Description
The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.
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K Number
K043388Device Name
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
Manufacturer
PEGASUS BIOLOGICS, INC.
Date Cleared
2005-08-05
(239 days)
Product Code
FTM, OWY, OXB, OXE
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OrthADAPT® Bioimplant (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, hernias, suture-line reinforcement, and reconstructive procedures. The device is also 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.
OrthADAPT® 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.
OrthADAPT® is intended for one-time use only.
Device Description
The OrthADAPT Bioimplant is a decellularized equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterillant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
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