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510(k) Data Aggregation
K Number
K070016Device Name
BLUE SHARK
Manufacturer
MERIDAN MEDICAL
Date Cleared
2007-04-02
(89 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MERIDAN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blue Shark is an external fixation device indicated for the rigid stabilization of complex fractures of the pelvic girdle. This external fixation device can be utilized for Type B and Type C fractures
Device Description
The pelvic external fixators are composed of four different elements composing the frame of the fixator connected by screws and rings. The fixator is assembled on four steel screws that are implanted into the pelvis on the iliac crest depending on the selected implantation.
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K Number
K032427Device Name
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
Manufacturer
MERIDAN MEDICAL
Date Cleared
2003-10-09
(64 days)
Product Code
JEC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MERIDAN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.
Device Description
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316LVM, ISO 5831-1/9.
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