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510(k) Data Aggregation
K Number
K083780Device Name
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
Manufacturer
AUDIO TECHNOLOGIES S.R.L.
Date Cleared
2009-03-23
(94 days)
Product Code
ETA, ETB
Regulation Number
874.3495Why did this record match?
Applicant Name (Manufacturer) :
AUDIO TECHNOLOGIES S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.
Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include. fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window.
Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical qauge (code 02.14) The implant must be carried out by a qualified surgeon.
Device Description
Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.
Otosurgical prosthesis of the middle hear, are manufactured from a wide variety of materials: titanium, poliethylene (PE), stainless steel, hydroxylapatite (HA). platinum (Pt). politetrafluoroethylene (PTFE), gold, polimetilxilossano (silicon) and Nitinol, or combination of these materials.
Numerous designs are available for replacement of any or all of the bones of the ossicular chain.
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K Number
K001142Device Name
AUDIO TECHNOLOGIES S:R.1
Manufacturer
AUDIO TECHNOLOGIES S.R.L.
Date Cleared
2000-06-23
(74 days)
Product Code
ETB
Regulation Number
874.3450Why did this record match?
Applicant Name (Manufacturer) :
AUDIO TECHNOLOGIES S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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