Search Results
Found 5 results
510(k) Data Aggregation
K Number
K251844Device Name
Kerecis SurgiBind (50241)
Manufacturer
Kerecis Limited
Date Cleared
2025-07-15
(29 days)
Product Code
OXH
Regulation Number
878.3300Why did this record match?
Product Code :
OXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K202430Device Name
Kerecis Reconstruct
Manufacturer
Kerecis Limited
Date Cleared
2021-05-02
(250 days)
Product Code
OXH
Regulation Number
878.3300Why did this record match?
Product Code :
OXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
Device Description
The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness. The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes: 4x7 cm, 7x10 cm, 7x20 cm. The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.
Ask a Question
K Number
K171357Device Name
SurgiMend PRS Meshed, Revize-X
Manufacturer
Integra LifeSciences Corporation (Owner of TEI Biosciences)
Date Cleared
2017-06-07
(29 days)
Product Code
OXH, FTM
Regulation Number
878.3300Why did this record match?
Product Code :
OXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.
Device Description
SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.
Ask a Question
K Number
K160400Device Name
Miromatrix Biological Mesh
Manufacturer
MIROMATRIX MEDICAL INC.
Date Cleared
2016-06-08
(117 days)
Product Code
OXH, FTM
Regulation Number
878.3300Why did this record match?
Product Code :
OXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Device Description
The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
Ask a Question
K Number
K150341Device Name
Miromatrix Biological Mesh RS
Manufacturer
MIROMATRIX MEDICAL INC.
Date Cleared
2015-05-12
(90 days)
Product Code
OXH
Regulation Number
878.3300Why did this record match?
Product Code :
OXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Device Description
The Miromatrix Biological Mesh RS is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
Ask a Question
Page 1 of 1