FDA Registration
Active
🇺🇸 United States
CENTEX MACHINING, INC.
Reg #: 1645151
·
FEI: 1000118610
·
Expires 2026
Products
33
Proprietary Names
52
Establishment Types
2
Classifications
33
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Registration Details
- Registration Name
- CENTEX MACHINING, INC.
- Registration Number
- 1645151
- FEI Number
- 1000118610
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1513 SAM BASS ROAD
- City
- Round Rock
- State
- TX
- ZIP
- 78681
- Country
- US
Owner / Operator
- Firm Name
- Centex Machining by Fathom
- Operator Number
- 10061953
- Address
- 1513 Sam Bass Rd.
- City
- Round Rock
- State
- TX
- Postal Code
- 78681
- Country
- US
- Correspondent
- Donald O Atkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-06-08 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-12-21 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2021-12-21 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-12-21 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2020-03-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-03-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-04-12 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2022-03-07 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2022-02-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-02-28 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2021-03-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-12-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-12-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-12-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-12-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-12-07 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-03-04 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-07-20 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2022-03-07 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2021-12-07 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2022-01-25 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2022-01-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-11-08 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-01-25 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2021-12-07 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2019-12-05 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2021-11-09 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2021-04-12 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-04-12 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2021-04-12 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-12-06 |
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 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
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
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
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL
Zimmer Biomet General Instrumentation (00-7712-057-00 Stem Driver)
Medtronic Sofamor Danek USA, 6279017 Threaded Inserter Outer
Zimmer 00-9975-035-02
Zimmer 00-9965-002-16, -18, -19
Zimmer 00-9975-002-13, -15, -16, -18, -19, -21, -22, -24, -25
Zimmer 00-9975-036-00, -10
Zimmer 00-9975-039-00
Zimmer Biomet
ZCA All-Poly Acetabular Cups
Zimmer Biomet 00585104455
Zimmer Biomet 00585104445
Zimmer Biomet 00585104412
Zimmer Biomet 00585104355
Zimmer Biomet 00585104465
Zimmer Biomet 00585104345
Zimmer Biomet 00585104365
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only