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Found 7 results
510(k) Data Aggregation
K Number
K071887Device Name
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
Manufacturer
ARTIMPLANT AB
Date Cleared
2007-09-18
(71 days)
Product Code
FTL, ADV
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SportMesh™ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. SportMesh™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
Device Description
SportMesh™ / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.
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K Number
K061956Device Name
ARTELON STT SPACER
Manufacturer
ARTIMPLANT AB
Date Cleared
2007-06-07
(331 days)
Product Code
KYI
Regulation Number
888.3770Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis.
Device Description
ARTELON STT Spacer is a woven one-piece, L-shaped implant made of ARTELON, a polycaprolactone based polyurethaneurea.
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K Number
K061954Device Name
ARTELON CMC SPACER ARTHRO
Manufacturer
ARTIMPLANT AB
Date Cleared
2007-06-01
(325 days)
Product Code
KYI, WRI
Regulation Number
888.3770Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artelon® CMC Spacer Arthro intended to be implanted into first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.
Device Description
ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea. ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device. ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.
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K Number
K052830Device Name
SPORTMESH
Manufacturer
ARTIMPLANT AB
Date Cleared
2006-01-19
(106 days)
Product Code
FTL, FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.
Device Description
Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.
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K Number
K052482Device Name
ARTELON SURGICAL SUTURE
Manufacturer
ARTIMPLANT AB
Date Cleared
2005-10-17
(38 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artelon® Surgical Suture is intended for use in general soft tissue approximation and/or ligation during surgery.
Device Description
ARTELON Surgical Sutures are nonabsorbable sterile surgical sutures (i.e. braided threads) prepared from ARTELON (polycaprolactone based poly (urethane urea)) in a multifilament form intended for soft tissue approximation. Due to limited stiffness of the sutures, they appear stretchy during handling. Although ARTELON sutures are nonabsorbable, they degrade slowly over time; the degradation occurs over a prolonged period of time with a gradual reduction of tensile strength of approximately 20% per year. ARTELON Surgical Sutures are uncoated and undyed. The sutures are supplied sterile.
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K Number
K040070Device Name
ARTELON SPACER CMC-1
Manufacturer
ARTIMPLANT AB
Date Cleared
2004-09-21
(251 days)
Product Code
KYI
Regulation Number
888.3770Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artimplant Artelon® Spacer CMC-I The Artelon™ Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal.
The device is intended to be used in thumb disabilities because of osteoarthritis.
Device Description
The Artelon™ Spacer CMC-I is a one-piece device intended to be implanted into the CMC-I joint and serve as an interpositional spacer between the trapezium bone and the first metacarpal bone.
It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form.
The Artelon™ Spacer CMC-I will be offered sterile.
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K Number
K032160Device Name
ARTELON SURGICAL SUTURE
Manufacturer
ARTIMPLANT AB
Date Cleared
2003-11-17
(125 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
ARTIMPLANT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.
Device Description
Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.
The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.
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