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510(k) Data Aggregation
K Number
K172937Device Name
Colorado Therapeutics Xenograft Implant
Manufacturer
Date Cleared
2017-10-25
(29 days)
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Colorado Therapeutics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
Device Description
Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rinsing or rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin, dry, and durable xenograft implant, which makes possible an advantageous xenograft product.
The only change in this Special 510(k) Notification is the addition of two sizes: 02x03cm and 04x04cm. These sizes are both outside the 36cm² and 90cm² sizes in K160181. This change represents a notification to the original device, K160181, and changes in dimensions are considered appropriate for review as a Special 510(k).
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K Number
K160181Device Name
COLORADO THERAPEUTICS XENOGRAFT IMPLANT
Manufacturer
Date Cleared
2016-10-20
(267 days)
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Colorado Therapeutics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
Device Description
Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin and dry xenograft implant that provides the suitable strength, and biocompatibility for a soft tissue repair implant.
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Ask a specific question about this device
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