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510(k) Data Aggregation
K Number
K040112Device Name
TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE
Manufacturer
TRI-MED, INC.
Date Cleared
2004-03-12
(52 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TriMed Bearing Plate is intended for use as an aid the fracture healing. The implants are applied to a to fracture hound secured with bone screws and threaded or unthreaded locking fixation pegs.
The TriMed Bearing Plate is indicated for:
1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion
Device Description
The TriMed Bearing Plate is a bone fixation plates are inc frined bound to fracture fixation. The plates are is ased as an an an either medical grade 316 stainless manalabourea (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136). freamfamilian which workeristics of the devices are provided in enclosures 8 and 9.
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K Number
K030877Device Name
TRIMED RADIAL BULLET
Manufacturer
TRI-MED, INC.
Date Cleared
2004-02-05
(322 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TriMed Radial Bullet is intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. The implant design includes a tip that is placed up against the subchondral bone of the tip of the radial styloid to prevent loss of radial length during fracture healing. The TriMed Radial Bullet may be used with bone screws, washers, locking bone screws and/or locking fixation pegs of the same material. The principal site of application is along the radial column in the context of distal radius fixation for treatment of fractures or osteotomies. Other sites of application may be reserved for future use.
The TriMed Radial Bullet is indicated for:
1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion
Device Description
The TriMed Radial Bullet is a bone fixation implant that is used as an aid to fracture fixation. All components of the implant are manufactured either from medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy.
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K Number
K010545Device Name
TBW
Manufacturer
TRI-MED, INC.
Date Cleared
2001-06-06
(103 days)
Product Code
NDL, LRN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.
Device Description
The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250".
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K Number
K961863Device Name
PARACENTESIS TRAYS
Manufacturer
TRI-MED, INC.
Date Cleared
1996-05-28
(14 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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