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510(k) Data Aggregation
K Number
K993027Device Name
ESKA MODULAR HIP SYSTEM
Manufacturer
SPECS USA, INC.
Date Cleared
2000-04-06
(210 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
SPECS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESKA Modular Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.
Device Description
The ESKA Modular Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems and heads, acetabular shells and modular liners, bipolar femoral heads, and bone screws. The femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. There are fully porous, proximally porous. collared and collarless options. The acetabular components are porous, with various liner options and screws for supplementary fixation. Pre-assembled bipolar and unipolar components are also available.
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K Number
K946349Device Name
STENODOC
Manufacturer
SPECS USA, INC.
Date Cleared
1996-05-24
(511 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SPECS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Detection and analysis of vascular disease in peripheral vessels. Evaluation of degree and site of a stenosis. Detection of occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.
Device Description
Stenodoc is a mains independent portable continuous wave Doppler ultrasound device with two pen-shaped split-D transducers operating at 4 MHz and 8 MHz. A 512 point fast Fourier transform (FFT) is performed on the returned signal. The spectral distribution of blood flow is represented as a frequency over time diagram with intensities represented by different shades of gray. The diagram is displayed on a liquid crystal display (LCD). Measurements can be annotated with the patient's name, vessel name and a diagnosis and can be stored on a built-in harddisk for later evaluation. Size: 3" x 13.5" x 10" (Height/Width/Depth) Weight: 9 lbs.
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