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Found 11 results
510(k) Data Aggregation
K Number
K150166Device Name
Extremity Medical Suture Anchor
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2015-02-23
(28 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
Device Description
The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.
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K Number
K143402Device Name
Extremity Medical Calcaneal Osteotomy Device
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2015-02-04
(68 days)
Product Code
HWC, HRS
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
Device Description
The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
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K Number
K121349Device Name
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2012-07-18
(75 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.
Device Description
The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.
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K Number
K121417Device Name
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2012-07-18
(68 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.
Device Description
The EXTREMITY MEDICAL Screw System
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K Number
K101700Device Name
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2010-10-12
(117 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
Device Description
The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.
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K Number
K093770Device Name
EXTREMITY MEDICAL SCREW SYSTEM
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2010-04-28
(141 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.
Device Description
The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws.
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K Number
K092548Device Name
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2009-12-15
(118 days)
Product Code
KYI
Regulation Number
888.3770Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:
- Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb)
- Decreased motion, pinch, and grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
- Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity
Device Description
The EXTREMITY MEDICAL Trapezium Prosthesis
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K Number
K091577Device Name
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2009-07-24
(52 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
Device Description
The EXTREMITY MEDICAL Midfoot Screw System
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K Number
K082934Device Name
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2009-04-23
(204 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints
Device Description
The EXTREMITY MEDICAL Midfoot Screw System
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K Number
K083151Device Name
EXTREMITY MEDICAL SUTURE ANCHOR
Manufacturer
EXTREMITY MEDICAL LLC
Date Cleared
2009-01-22
(90 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures
Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction
Device Description
The EXTREMITY MEDICAL Suture Anchor
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