MedtechSourcebook

TriPoint Surgical

Contract manufacturer · Columbia City, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3009973844 (openFDA record; or search FDA's registration database)
FEI number
3009973844
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
TriPoint Surgical (FDA owner/operator no. 10042633)
Registered address
201 S Towerview Dr, Columbia City, IN 46725
Contract listings
12 device listings, 13 product codes, first listed Dec 14, 2012
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
HTOReamerClass IOrthopedicContract manufacturingApr 13, 2016
HTPFileClass IOrthopedicContract manufacturingApr 13, 2016
HTQBroachClass IOrthopedicContract manufacturingDec 14, 2012
HTRRaspClass IGeneral and plastic surgeryContract manufacturingApr 13, 2021
HTWBit, DrillClass IOrthopedicContract manufacturingMar 11, 2016
HWDStarter, Bone ScrewClass IOrthopedicContract manufacturingApr 13, 2016
HWJAwlClass IOrthopedicContract manufacturingApr 13, 2016
HWXTap, BoneClass IOrthopedicContract manufacturingApr 13, 2016
HXXScrewdriverClass IOrthopedicContract manufacturingApr 13, 2016
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedClass IIOrthopedicContract manufacturingJan 13, 2020
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedClass IIOrthopedicContract manufacturingJan 13, 2020
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingApr 13, 2016
LYSBone MillClass IOrthopedicContract manufacturingOct 11, 2019