Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722824

FEI Number

1000306276

Entity Name

LENOX-MACLAREN SURGICAL CORP.

City/State/Country

LOUISVILLE, CO, US

Establishment Address

657 S Taylor Ave Ste A, LOUISVILLE, CO 80027, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LENOX-MACLAREN SURGICAL CORP. (Owner Number: 9012017)

Owner / Operator Contact Address

657 SOUTH TAYLOR AVE., No. A, Louisville, CO 80027, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN LENOX MACLAREN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1994-11-29
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	1995-02-14
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1994-11-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1995-02-14
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	1995-02-14
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-02-14
HWA	Impactor	Orthopedic	Class 1	888.4540	1995-02-14
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-11-29
EIG	Retractor, All Types	Dental	Class 1	872.4565	1995-02-14
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	1995-02-14

Official Correspondent

Robert Williams

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LENOX-MACLAREN SURGICAL CORP.

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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3015398570	MEISTER SURGICAL INSTRUMENTS	Sialkot Punjab, PK
3007773213	SITEC (PVT.) LTD.	SIALKOT Punjab, PK
3008808049	SURGICRAFTS	Sialkot Punjab, PK
9613083	TOWNE BROTHERS (PVT.), LTD.	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722824. Last updated year: 2026. Please use registration number 1722824 when referencing this establishment in official correspondence.