MedtechSourcebook

Pivot International

Contract manufacturer · Lenexa, KS

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

FDA registration
1000655158 (openFDA record; or search FDA's registration database)
FEI number
1000655158
Registered for
FDA registration year 2026
Establishment types
Specification developer; Contract manufacturer
Owner or operator
Pivot International Inc (FDA owner/operator no. 10043496)
Registered address
11030 Strang Line Rd, Lenexa, KS 66215
Contract listings
3 device listings, 3 product codes, first listed Jul 19, 2018
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
FWZOperating Room Accessories Table TrayClass IGeneral and plastic surgeryContract manufacturingJul 19, 2018
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefClass IINeurologyContract manufacturingFeb 2, 2023
QPBSystem, Suction, Lipoplasty For RemovalClass IIGeneral and plastic surgeryContract manufacturingJul 2, 2025