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510(k) Data Aggregation
K Number
K060151Device Name
ORBITAL TISSUE EXPANDER (OTE)
Manufacturer
INNOVIA, LLC
Date Cleared
2006-08-08
(200 days)
Product Code
NFM
Regulation Number
886.3320Why did this record match?
Product Code :
NFM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.
Device Description
The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.
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K Number
K010852Device Name
OSMED TISSUE EXPANDER
Manufacturer
IOP, INC.
Date Cleared
2001-08-13
(145 days)
Product Code
NFM
Regulation Number
886.3320Why did this record match?
Product Code :
NFM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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