Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1645151

FEI Number

1000118610

Entity Name

CENTEX MACHINING, INC.

City/State/Country

Round Rock, TX, US

Establishment Address

1513 SAM BASS ROAD, Round Rock, TX 78681, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Centex Machining by Fathom (Owner Number: 10061953)

Owner / Operator Contact Address

1513 Sam Bass Rd., Round Rock, TX 78681, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zimmer Biomet 42-5399-035-14 TM REVERSE SHOULDER INSTRUMENT LCCK Instruments Zimmer 00-9965-002-16 Zimmer 00-9965-002-19 Zimmer 00-9965-002-18 HINGE KNEE MISC Zimmer Persona Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES ZIMMER NEXEL TOTAL ELBOW Zimmer Biomet 00579105400 Zimmer Biomet 42-5399-035-14 Zimmer Persona Knee System SEG RHK KN INSTRUMENTS Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Proximal Reamer 6MM Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Reamer Body 8MM Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Reamer Body 6MM Nanovis 6208X41 Series Nanovis 6208X86 Series Nanovis 6208X64 Series Nanovis HINGE KNEE MISC NK FLEX A/S PROV KIT KNEE AUSTIN INSTRUMENTS STEMMED PROV N/KNEE II MOST KNEE MIS INSTR N/KNEE II MOST KNEE MIS INSTRUMENTS PERSONA Partial Knee System TIBIAL PATIENT SPEC SURG INST Medtronic Spine: CFN 803-108 N/KNEE II COCR RMER/GDES TB BS N/KNEE II REV KNEE INSTRUMENTS KNEE AUSTIN INSTRUMENTS N/KNEE II MOST KNEE MIS INSTR N/KNEE II REV KNEE INSTRUMENTS NK FLEX A/S PROV KIT Zimmer Biomet 00119300300 Zimmer Nexel Total Elbow Articulation Extractor Zimmer Nexel Total Elbow Humeral Extractor Plate, Size 4 Zimmer Nexel Total Elbow Humeral Extractor Plate, Size 5/6 Zimmer Nexel Total Elbow Ulnar Stem Inserter HINGE KNEE MISC ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL Zimmer Persona Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES Zimmer Biomet General Instrumentation (00-7712-057-00 Stem Driver) ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL Zimmer 00-9965-002-18 Zimmer 00-9965-002-19 Zimmer 00-9965-002-16

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2020-06-08
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-12-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-12-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-12-21
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2020-03-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-03-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-04-12
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2021-04-12
HWB	Extractor	Orthopedic	Class 1	888.4540	2022-03-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-02-28
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-02-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-02-28
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2021-03-01
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-12-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-11-09
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2021-12-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-12-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-12-07
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2021-12-07
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2021-12-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-12-07
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2021-12-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-12-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-03-04
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-07-20
HWK	Trephine	Orthopedic	Class 1	888.4540	2022-03-07
HWA	Impactor	Orthopedic	Class 1	888.4540	2021-12-07
KTZ	Caliper	Orthopedic	Class 1	888.4150	2022-01-25
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2022-01-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-12-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-11-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-12-07
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-01-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-12-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-12-05
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2021-03-04
HWB	Extractor	Orthopedic	Class 1	888.4540	2021-12-07
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-03-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-02-28
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2021-11-09
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-03-01
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-12
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2021-04-12
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2021-04-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-04-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-04-12
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2021-04-12
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2021-04-12
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2021-04-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-04-12

Official Correspondent

Donald Atkins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Centex Machining by Fathom

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
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K220628	Waldemar Link GmbH & Co. KG	LINK Endo-Model EVO Knee System	2022-05-03
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1645151. Last updated year: 2026. Please use registration number 1645151 when referencing this establishment in official correspondence.