Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011061242

FEI Number

3011061242

Entity Name

Advanced Machine, Inc.

City/State/Country

Winchester, TN, US

Establishment Address

119 Creasman Dr, Winchester, TN 37398, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Advanced Machine, Inc. (Owner Number: 10047389)

Owner / Operator Contact Address

119 Creasman Drive, Winchester, TN 37398, 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
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-08-20
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2014-08-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-08-20
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2014-08-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2014-08-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-08-20
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-08-20
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2014-08-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2014-08-20

Official Correspondent

Todd Stovall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Machine, 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
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

Similar Registrations

Registration Number	Establishment Name	Location
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3036795921	KLS MARTIN SE & CO. KG	Fridingen Baden-Wurttemberg, DE
1020279	SMITH & NEPHEW, INC.	MEMPHIS, TN, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
3012755988	Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011061242. Last updated year: 2026. Please use registration number 3011061242 when referencing this establishment in official correspondence.