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510(k) Data Aggregation
K Number
K073331Device Name
DVO EXTENDED ARTICULATION HUMERAL HEADS
Manufacturer
DVO EXTREMITY SOLUTIONS, LLC
Date Cleared
2008-02-19
(84 days)
Product Code
HSD
Regulation Number
888.3690Why did this record match?
Applicant Name (Manufacturer) :
DVO EXTREMITY SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVO™ Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for:
1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
3. Rotator cuff tear arthropathy.
Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.
Device Description
The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hemi Shoulder System. The cobalt chrome alloy, semispherical heads mate with the previously cleared humeral stems through a locking taper. The heads are highly polished. They do not articulate with the previously cleared glenoids as they are intended to be used in hemi-arthroplasty applications only.
The heads are available in four sizes, 44 to 56mm, in 4mm increments, and in heights of 18 and 21 mm.
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K Number
K060988Device Name
TOTAL AND HEMI SHOULDER SYSTEM
Manufacturer
DVO EXTREMITY SOLUTIONS, LLC
Date Cleared
2006-12-06
(240 days)
Product Code
KWS, HSD, MBF
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
DVO EXTREMITY SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVOTM Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.
The DVO™ Total and Hemi Sl»vulder System is indicated for:
- 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
- Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- నే. Other difficult clinical problems where shoulder anthrodesis or resection arthroplasty are not acceptable (c.g., revision of a failed primary component).
Hemi-shoulder replacement is also indicated for:
- 1. Ununited humeral head fractures;
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff tear arthropathy.
Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.
This is a single use device.
Device Description
This sterile modular total and hemi shoulder system is comprised of a humeral stem, two styles of humeral heads (standard and exentric) and two styles of glenoids (pegged or keeled). The heads mate on the stems through a locking taper. The heads are highly polished and articulate with the glenoids.
The humeral stems are offered in two lengths: standard (110mm with diameters of 6 to 16mm) or long (200 to 220mm in length with diameters of 8 to 14mm). The stems are fluted, except for the 6mm diameter stem. The stems also have fins with suture holes. The head is available in 15 standard sizes (40 to 56mm in heights of 15, 18 and 21 mm) and 10 eccentric sizes (40 to 56mm in heights of 18mm or 21mm).
Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.
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K Number
K052754Device Name
WRIST FUSION PLATE
Manufacturer
DVO EXTREMITY SOLUTIONS, LLC
Date Cleared
2005-10-27
(27 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DVO EXTREMITY SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability, post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; turnor resection; and spastic deformities. Single use device for cementless use only.
Device Description
These anatomically contoured plates are offered in two lengths (standard or short), manufactured from either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229). The plate contains a single row of screw holes (2.4mm, 2.7mm and 3.2mm in diameter) down its length. The locking screws are 2.4mm in diameter and vary in length from 6mm to 14mm. The 2.7mm and 3.2mm screws were previously cleared. In addition to the screws, the device utilizes a press fit intramedullary fixation for the proximal stem.
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K Number
K052150Device Name
VOLAR PLATE SYSTEM
Manufacturer
DVO EXTREMITY SOLUTIONS, LLC
Date Cleared
2005-09-08
(31 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DVO EXTREMITY SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVO™ Volar Plate System is intended for volar fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.
Device Description
This non-sterile volar plate system offers several sizes and styles of volar plates, in either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM 2229). The three versions include a volar T-plate, a volar intramedullary T-plate and a volar T-plate with translating head. The distal head of the plate contains two rows of fixed angle screw holes that accept 2.7 mm screws. Dorsal and ulnar sheaths are secured into the plate recesses to cover the screw heads. The screws vary in length from 16mm to 26mm. K-wires may also be used for stabilization of bone fragments.
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