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510(k) Data Aggregation
K Number
K082017Device Name
STARR FRAME STEINMANN PIN
Manufacturer
Date Cleared
2008-10-10
(86 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
STARR FRAME LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Starr Frame Steinmann Pins are non-sterile, single use, fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system.
Device Description
The Starr Frame Steinmann Pins consist of various fixation pins and are offered in assorted dimensions and configurations to accommodate physician preferences, physical profiles of different patients, and varying injuries and conditions. The devices are constructed of implant grade 316LVM stainless steel. They are provided non-sterile and intended for single-use only.
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