FDA.reportPublic FDA data

Traction Pin Kit

Primary DI
M791TPK1237HTA0
Brand
Traction Pin Kit
Company
BIOACCESS INC
Model
TPK1237HTA
Catalog number
TPK-1237-HTA
Device description
Features: • one BioAccess High Torque Small Bone Tool with Keyless Chuck Attached, SBT-1005HTA • one Prep Kit • two Steinmann Pin, (2.0 mm) 5/64" x 9", Diamond Point on One End • one Pin protectors, Pink, 2.0mm • one ChloraPrep, tinted 10.5ml applicator • two 7 1/4 Tube Occluding Forcep
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M791TPK1237HTA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(410) 675-8586customerservice@bioaccess.com

Regulatory Flags#

DUNS number
942203001
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M791TPK1253HTA0Traction Pin KitTPK1253HTATPK-1253-HTA2026-09-04
M791NGD10000Next Gen DriverNGD10002022-08-04
M791NGD1005A0Next Gen DriverNGD1005A2022-08-04
M791SBT10000Small Bone ToolSBT10002022-08-04
M791SBT1000HT0Small Bone ToolSBT1000HT2022-08-04
M791SBT10010Small Bone ToolSBT10012022-08-04
M791SBT1001A0Small Bone ToolSBT1001A2022-08-04
M791SBT10040Small Bone ToolSBT10042022-08-04
M791SBT10050Small Bone ToolSBT10052022-08-04
M791SBT10050620Small Bone ToolSBT10050622022-08-04
M791SBT1005HTA0Small Bone ToolSBT1005HTA2022-08-04
M791WF1000Wire FixationWF1002022-08-04
M791MH21500BioAccess Marrow Collection SystemMH21502022-08-03
M791TPK12080Traction Pin KitTPK12082019-12-10
M791TPK11040Traction Pin KitTPK11042018-09-20
M791TPK1200HT0Traction Pin KitTPK1200HT2018-09-20
M791TPK12010Traction Pin KitTPK12012018-09-20
M791TPK1201HT0Traction Pin KitTPK1201HT2018-09-20
M791TPK1203HT0Traction Pin KitTPK1203HT2018-09-20
M791TPK1207HTA0Traction Pin KitTPK1207HTA2018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
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
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22