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510(k) Data Aggregation
K Number
K111584Device Name
XYLOS MACRO-POROUS SURGICAL MESH
Manufacturer
XYLOS CORPORATION
Date Cleared
2011-08-25
(79 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xylos® Macro-Porous Surgical Mesh is intended to be used for implantation to reinforce and protect 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. This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Xylos® Macro-Porous Surgical Mesh 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. Xylos® Macro-Porous 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.
Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.
Device Description
Xylos® Macro-Porous Surgical Mesh is a flexible, non-resorbable implant composed of microbial-derived cellulose; there are no animal or human derived components in the device. Xylos® Macro-Porous Surgical Mesh is strong, conformable, biocompatible and includes macro-pores to facilitate tissue in-growth. The device is not subject to degradation or weakening by the action of tissue enzymes.
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K Number
K100984Device Name
XYLOS VESSEL GUARD
Manufacturer
XYLOS CORPORATION
Date Cleared
2010-07-07
(90 days)
Product Code
OMR, PRE
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
XYLOS™ Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
Device Description
XYLOS™ Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbialderived cellulose. The device is presented ready-to-use in a sterile double-pouched package. It is intended for one time use.
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K Number
K090880Device Name
XYLOS POROUS SURGICAL MESH
Manufacturer
XYLOS CORPORATION
Date Cleared
2009-05-27
(57 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
Device Description
Xylos® Porous Surgical Mesh is a sterile, non-resorbable product composed of solvent-dehydrated, microbial-derived cellulose. The implantable unit is presented in sterile double-pouched packages for appropriate removal in preparation for surgery.
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K Number
K090778Device Name
MTA PROTECTIVE SHEET
Manufacturer
XYLOS CORPORATION
Date Cleared
2009-04-28
(36 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.
Device Description
MTA Protective Sheet is composed of microbial-derived cellulose. The non-resorbable surgical mesh is used for the management and protection of tendon injuries. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery.
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K Number
K083823Device Name
SECURIAN TISSUE REINFORCEMENT MATRIX
Manufacturer
XYLOS CORPORATION
Date Cleared
2009-03-18
(86 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Securian™ Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. Securian™ Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. Securian™ Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Securian™ Tissue Reinforcement 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. Securian™ Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. Securian™ Tissue Reinforcement Matrix is intended for one-time use.
Device Description
Securian™ Tissue Reinforcement Matrix is a sterile product composed of microbial-derived cellulose. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery. The non-resorbable surgical mesh is used for trauma and reconstructive surgical procedures involving tendons or other soft tissues. Securian™ Tissue Reinforcement Matrix maintains the relative position and stability of soft tissues during the healing period.
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K Number
K081882Device Name
MODIFICATION TO XYLOS SURGICAL MESH
Manufacturer
XYLOS CORPORATION
Date Cleared
2008-07-11
(9 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
Device Description
The XYLOS Surgical Mesh will function as a non-absorbable surgical biomaterial that enables rapid fixation by tissue incorporation. The device incorporates a microporous structure that ensures early fixation to host tissue with minimal foreign body response. The double-pouched, sterile, single use unit is designed to allow maintenance of the sterile field prior to implantation. The material is conducive to size with sterile surgical instruments to avoid excessive tension on the suture line.
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K Number
K023237Device Name
XYLOS SURGICAL MESH
Manufacturer
XYLOS CORPORATION
Date Cleared
2003-03-18
(172 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
Device Description
XYLOS™ Surqical Mesh is prepared from microbial derived cellulose that undergoes chemical processing inclusive of solvent dehydration. Units are cut in various sizes to meet surgical needs. Each unit is double-pouched, labeled, and gamma sterilized surgical mesh exhibits excellent tensile strength, suture retention and consistent thickness.
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K Number
K024054Device Name
XYLOS XCELL ANTIMICROBIAL DRESSING
Manufacturer
XYLOS CORPORATION
Date Cleared
2003-03-07
(88 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XCell® Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.
The device is intended for one-time use.
Device Description
Not Found
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K Number
K974251Device Name
X-CELL WOUND DRESSING
Manufacturer
XYLOS CORPORATION
Date Cleared
1998-06-22
(221 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
XYLOS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
X-Cell™, a hydrogel wound dressing is a device intended to cover a wound or burn on a patient's skin to absorb wound exudate, and protect against abrasion, friction, dessication, or external contamination. The moist environment has a cooling effect that may reduce pain.
X-Cell™ wound dressing may be used for the management of:
- Partlal to Full thickness wounds (arterial, venous, pressure and diabetic ulcers); .
- First and Second degree burns (severe sunbum, etc.); .
- Post-operative surgical wounds; .
- Donor sites; .
- Dermal Lesions (cuts, abrasions, exc.) .
Device Description
X-Cell™, a hydrogel wound dressing
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