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510(k) Data Aggregation
K Number
K053513Device Name
T-PIN
Manufacturer
Date Cleared
2006-01-13
(28 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
UNION SURGICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Union Surqical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.
Device Description
The Union Surgical. LLC T-Pin® is a threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures. The device incorporates a break-off shank. The device is ontionally supplied with removal tools that permit pin extraction and a sterilization tray.
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K Number
K032532Device Name
TARAS THREADED FIXATION PIN
Manufacturer
Date Cleared
2003-10-22
(68 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
UNION SURGICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Union Surgical, LLC Threaded Fixation Pins are intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.
Device Description
The Union Surgical, LLC Taras Threaded Fixation Pins are threaded stainless steel Steinmann pins used for the repair of wrist fractures. The device incorporates a break-off shank. The device is optionally supplied with removal tools that permit pin extraction.
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