Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010057661

FEI Number

3010057661

Entity Name

HIGH-TECH QUALITY MFG. INC.

City/State/Country

Salt Lake City, UT, US

Establishment Address

2064 Alexander St Ste D, Salt Lake City, UT 84119, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

High Tech Management Corporation (Owner Number: 10043098)

Owner / Operator Contact Address

2064 Alexander St., Suite D, Salt Lake City, UT 84119, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-02-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-24
HXB	Probe	Orthopedic	Class 1	888.4540	2026-02-24

Official Correspondent

Corinna Garcia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

High Tech Management Corporation

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3040335671	Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork (County), IE
3010363503	FRUEH VERPACKUNGSTECHNIK AG	Fehraltorf Zurich, CH
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3010673850	MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010057661. Last updated year: 2026. Please use registration number 3010057661 when referencing this establishment in official correspondence.