MedtechSourcebook

Advanced Machine, Inc.

Contract manufacturer · Winchester, TN

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

FDA registration
3011061242 (openFDA record; or search FDA's registration database)
FEI number
3011061242
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Advanced Machine, Inc. (FDA owner/operator no. 10047389)
Registered address
119 Creasman Dr, Winchester, TN 37398
Contract listings
7 device listings, 15 product codes, first listed Aug 20, 2014
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
FZXGuide, Surgical, InstrumentClass IGeneral and plastic surgeryContract manufacturingAug 20, 2014
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedClass IIOrthopedicContract manufacturingAug 20, 2014
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
HTJGauge, DepthClass IOrthopedicContract manufacturingAug 20, 2014
HXXScrewdriverClass IOrthopedicContract manufacturingAug 20, 2014
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedClass IIOrthopedicContract manufacturingAug 20, 2014
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedClass IIOrthopedicContract manufacturingAug 20, 2014
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingAug 20, 2014
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingAug 20, 2014