Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010065126

FEI Number

3010065126

Entity Name

RAYCO STEEL PROCESS, INC.

City/State/Country

Warsaw, IN, US

Establishment Address

207 S Lincoln St, Warsaw, IN 46580, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Rayco Steel Process, Inc. (Owner Number: 10043080)

Owner / Operator Contact Address

207 S. Lincoln St., Warsaw, IN 46580, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet Zimmer Biomet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2018-08-20
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-23
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2016-05-10
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2018-11-21
HXC	Wrench	Orthopedic	Class 1	888.4540	2018-11-21
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-23
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-11-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-06-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-06-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-06-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-06-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-11-21
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2018-11-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-11-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-11-21
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2018-11-21
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-11-21
HWK	Trephine	Orthopedic	Class 1	888.4540	2018-11-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-23
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-06-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-06-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-06-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-07-01
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2020-09-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-09-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-08-17
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-23
HXW	Bender	Orthopedic	Class 1	888.4540	2018-11-21

Official Correspondent

Blake Pilcher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rayco Steel Process, 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
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0012-2019	Exactech, Inc.	2	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010065126. Last updated year: 2026. Please use registration number 3010065126 when referencing this establishment in official correspondence.