Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040265659

FEI Number

3040265659

Entity Name

TRIO MEDICAL MANUFACTURING

City/State/Country

Leland, NC, US

Establishment Address

9244 Industrial Blvd Ne, Leland, NC 28451, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Trio Medical Manufacturing (Owner Number: 10093972)

Owner / Operator Contact Address

9244 Industrial Blvd NE, Leland, NC 28451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swivelux Retractor NEXLIF Retractor NEXLIF Instrument System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-08-26
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2025-08-26

Official Correspondent

Leighton LaPierre

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trio Medical Manufacturing

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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
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 3040265659. Last updated year: 2026. Please use registration number 3040265659 when referencing this establishment in official correspondence.