FDA.reportPublic FDA data

iTool®

Primary DI
06957277203150
Brand
iTool®
Company
Apex (Guangzhou) Tools & Orthopedics Co.
Model
KQ-07104NT
Catalog number
KQ-07104NT
Device description
"K-WIRE D.TROCAR PT. 4"" .028"" (0.7MM)"
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121004000APEX KIRSCHNER WIRES AND STEINMANN PINSApex Tools & Orthopedics Co.2012-04-24HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06957277203150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06957277203150069572772031506957277203150

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529936792
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06957277203167iTool®KQ-14104NTKQ-14104NT2026-05-15
06957277203174iTool®KQ-09109NTKQ-09109NT2026-05-15
06957277203181iTool®KQ-09106NTKQ-09106NT2026-05-15
06957277203198iTool®KQ-11109NTKQ-11109NT2026-05-15
06957277203204iTool®KQ-16104NT KQ-16104NT 2026-05-15
06957277203211iTool®SQ-20109NTSQ-20109NT2026-05-15
06957277203228iTool®SQ-20609NTSQ-20609NT2026-05-15
06957277203235iTool®SQ-24109NTSQ-24109NT2026-05-15
06957277203242iTool®SQ-28109NTSQ-28109NT2026-05-15
06957277203112iTool®112-04112-042025-10-31
06957277203129iTool®112-02112-022025-10-31
06957277203136iTool®112-01112-012025-10-31
06957277202603AWI209-042024-03-06
06957277202610AWI209-062024-03-06
06957277202504AWI209-00-68209-00-682023-08-11
16957277200354AWI209-00-68209-00-682023-08-11
06957277201583AWI210-01210-012022-03-02
06957277201590AWI210-02210-022022-03-02
16957277201580AWI210-01210-012022-03-02
16957277201597AWI210-02210-022022-03-02

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Primary DI, Brand, Company table
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00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
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