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510(k) Data Aggregation
K Number
K122777Device Name
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
Manufacturer
Date Cleared
2013-05-15
(246 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NUTEK ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NBX® Non-Bridging External Fixator – Hand, is used for definitive external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the metacarpals and phalanges of the hand.
Device Description
The NBX® Non-Bridging Fixator - Hand is provided sterile. The fixator consists of the body with its proprietary locking mechanism and a multiple of pins.
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K Number
K082833Device Name
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
Manufacturer
Date Cleared
2009-02-05
(132 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NUTEK ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.
Device Description
The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.
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