MedtechSourcebook

SHALBY ADVANCED TECHNOLOGIES, INC.

Contract manufacturer and sterilizer · El Dorado Hills, CA

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

FDA registration
3020155054 (openFDA record; or search FDA's registration database)
FEI number
3020155054
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Contract sterilizer
Owner or operator
Shalby Advanced Technologies, Inc. (FDA owner/operator no. 10082275)
Registered address
1115 Windfield Way, El Dorado Hills, CA 95762
Contract listings
3 device listings, 5 product codes, first listed Jul 20, 2021
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
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass IIOrthopedicContract manufacturingJul 10, 2024
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass IIOrthopedicContract sterilizationJul 10, 2024
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingMay 22, 2024
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract sterilizationJul 20, 2021
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedClass IIOrthopedicContract manufacturingJul 10, 2024
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedClass IIOrthopedicContract sterilizationJul 10, 2024
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingMay 22, 2024
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerClass IIOrthopedicContract sterilizationJul 20, 2021
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveClass IIOrthopedicContract manufacturingMay 22, 2024
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveClass IIOrthopedicContract sterilizationJul 20, 2021