NSI-US, Inc.

FDA Device Registration & Listing · Colorado Springs, CO, US · Registration 3008236502

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008236502
FEI Number
3008236502
Entity Name
NSI-US, Inc.
City/State/Country
Colorado Springs, CO, US
Establishment Address
5920 Paonia CT, Colorado Springs, CO 80915, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NSI Health Systems (DBA) NSI-US, Inc. (Owner Number: 10031218)
Owner / Operator Contact Address
5920 Paonia CT, Colorado Springs, CO 80915, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Retractor Assembly

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAD Retractor General, Plastic Surgery Class 1 878.4800 2010-01-04

Official Correspondent

Edwin Horn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NSI Health Systems (DBA) NSI-US, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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3032847175 BIOPHYX SURGICAL, INC. Edgewater, MD, US
9681129 BEMA-GMBH & CO. KG EMMINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008236502. Last updated year: 2026. Please use registration number 3008236502 when referencing this establishment in official correspondence.
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