Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2531782

FEI Number

3002546832

Entity Name

SIGMA INSTRUMENTS, INC.

City/State/Country

CRANBERRY TOWNSHIP, PA, US

Establishment Address

506 THOMSON PARK DR., CRANBERRY TOWNSHIP, PA 16066, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIGMA INSTRUMENTS, I (Owner Number: 9039899)

Owner / Operator Contact Address

506 THOMSON PARK DR., --, Cranberry Twp, PA 16066, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962239

PMA Number

N/A

All Registered Proprietary Names

Yamasaki System Ultralign SA201 ProAdjuster

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXM	Manipulator, Plunger-Like Joint	Unknown	Class U	N/A	2007-12-18

Official Correspondent

JOHN CRUNICK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIGMA INSTRUMENTS, I

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2531782. Last updated year: 2026. Please use registration number 2531782 when referencing this establishment in official correspondence.