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510(k) Data Aggregation
K Number
K022423Device Name
EXTERNAL FIXATION RING
Manufacturer
RIGID FX ORTHOPEDICS, INCORPORATED
Date Cleared
2002-09-17
(55 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
RIGID FX ORTHOPEDICS, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
Device Description
This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.
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K Number
K020311Device Name
CLEARVIEW WRIST FIXATOR
Manufacturer
RIGID FX ORTHOPEDICS, INCORPORATED
Date Cleared
2002-04-29
(90 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
RIGID FX ORTHOPEDICS, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:
- fractures of the wrist with ligamentous instability .
- comminuted intra-articular radius fractures
- post-traumatic reconstruction for joint stiffness .
- Colles Fracture .
- distal radius fractures (Types B and C) .
- Frykman Type III, IV, VII and VIII radius fractures
- any wrist fracture requiring distraction
Device Description
The device is a preassembled, mechanically adjustable external fixator and is available in three sizes (small, medium, and large). It is a four-piece construct consisting of a radiolucent polycarbonate plastic and applied to the bone with 2 pairs, with the option of a third pair, of self-drilling half-pins measuring 3mm x 110mm both cancellous and cortical. The half pins are used as bone anchors and are manufactured from medical grade stainless steel (316LVM).
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