MedtechSourcebook

SPECTRUM ASSEMBLY INC.

Contract manufacturer · Carlsbad, CA

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

FDA registration
3002672225 (openFDA record; or search FDA's registration database)
FEI number
3002672225
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
SPECTRUM ASSEMBLY INC. (FDA owner/operator no. 9103619)
Registered address
6300 Yarrow Dr, SUITE 100, Carlsbad, CA 92011
Contract listings
6 device listings, 8 product codes, first listed Oct 11, 2017
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
DQKComputer, Diagnostic, ProgrammableClass IICardiovascularContract manufacturingNov 22, 2021
FTCLight, Ultraviolet, DermatologicalClass IIGeneral and plastic surgeryContract manufacturingOct 11, 2017
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Class IINeurologyContract manufacturingSep 8, 2026
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Class IINeurologyContract manufacturingSep 8, 2026
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefClass IINeurologyContract manufacturingSep 17, 2021
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedClass IIRadiologyContract manufacturingSep 8, 2026
LLZSystem, Image Processing, RadiologicalClass IIRadiologyContract manufacturingSep 8, 2026
OWBInterventional Fluoroscopic X-Ray SystemClass IIRadiologyContract manufacturingSep 8, 2026