Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1836357

FEI Number

3003064967

Entity Name

C+A TOOL ENGINEERING, INC.

City/State/Country

Churubusco, IN, US

Establishment Address

4100 N. US 33, Churubusco, IN 46723, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MinebeaMitsumi Inc. (Owner Number: 10055758)

Owner / Operator Contact Address

3-9-6 Mita, Minato-ku, JP-13 108-8330, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

accessories,arthroscopic bit, drill ZMR Hip System CD HORIZON® SOLERA® VOYAGER Spinal System MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA ELEOS Limb Salvage System with BioGrip guide, surgical, instrument NEXGEN ANTERIOR FEMORAL CUTTING GUIDE NEXGEN INTRAMEDULLARY INSTRUMENTS Glenoid SIGMA SP1*DIS F CT BK SLOT 9MM SPAC SP2*DIS F CT BK SLOT 9MM SPAC SP2*DIS F CT BK NSLT 10MM SPAC ELEOS Limb Salvage System with BioGrip pin, fixation, smooth WIRE & STEINMAN PINS bone mill screwdriver CD Horizon ModuLeX Spinal System CD Horizon(TM) Spinal System orthopedic manual surgical instrument PROSTALAC EXCEL CD HORIZON® Spinal System Soft Graft Tamp; Wire Tamp PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM ANTERALIGN Spinal System with Titan nanoLOCK Surface Technology EXCEL extractor PROSTALAC SP2FEMNTCHGD BSH13MM5DG+2R/-2L SP*2 F NOT GD BH,13M/7D 0 OFFS SP*2 F NOT GD BUS IM/5D 0 OFFS SPEC2*TB CE ST PUN1.5-3SZ13X60 SP*2 F NOT GD BUS IM/7D 0 OFFS SP2FEMNTCHGD BSH15MM5DG+2L/-2R SP2FEM NTCH GDBUSHIM5DG+2R/-2L SP2FEM NTCH GDBUSHIM7DG+2L/-2R SP2FEMNTCHGD BSH13MM5DG+2L/-2R SP2FEM NTCH GDBUSHIM7DG+2R/-2L SP*2 TB CE STM PUN/SZ4-6/15X30 SP2FEMNTCHGD BSH13MM7DG+2L/-2R SP*2 TB CE STM PUN/SZ4-6/15X60 SP*2 F NOT GD BH,15M/7D 0 OFFS SP*2 F NOT GD BH,13M/5D 0 OFFS SP2FEMNTCHGD BSH15MM5DG+2R/-2L SP2FEMNTCHGD BSH15MM7DG+2R/-2L SP2FEMNTCHGD BSH13MM7DG+2R/-2L SPEC2*TB CE ST PUN1.5-3SZ13X30 SP2*DIS F CT BK SLOT 11MM SPAC SP2FEM NTCH GDBUSHIM5DG+2L/-2R PFC STEM TRIAL EXTRACT SP*2 F NOT GD BH,15M/5D 0 OFFS SP2FEMNTCHGD BSH15MM7DG+2L/-2R Impactor Biomet Impactor Vanguard ARTiC-XL 3D Ti Spinal System with TiONIC Technology ARTiC-L 3D Ti Spinal System with TiONIC Technology ARTiC-L Spinal System PROSTALAC instrument, manual, surgical, general use Echo FX Glenoid Gauge, Depth T2 ALTITUDE Expandable Corpectomy System VERTEX® Reconstruction System FREEDOM CONSTRAINED LINERS ANTERALIGN Spinal System with Titan nanoLOCK Surface Technology S-ROM driver, prosthesis SUMMIT Retractor Glenoid CD HORIZON® SOLERA® VOYAGER Spinal System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2017-10-05
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-10-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2019-07-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-07-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-07-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-07-29
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2019-07-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-10-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-10-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2017-10-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-10-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-10-05
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2017-10-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-10-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-12-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-12-08
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2022-12-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-12-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-12-08
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-10-06
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2017-10-05
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2022-12-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-12-08
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-12-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-12-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-12-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-12-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-10-05
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2017-10-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-10-05
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-10-05
HWJ	Awl	Orthopedic	Class 1	888.4540	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-04-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-10-05
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-10-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2017-10-05
HXG	Tamp	Orthopedic	Class 1	888.4540	2018-11-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-09-29
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-10-05
HWA	Impactor	Orthopedic	Class 1	888.4540	2017-10-06
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	2022-06-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-02-16
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2017-10-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2017-10-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-10-06
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-12-08
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-12-08
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2017-10-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-10-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-09-29
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2017-10-05
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2017-10-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MinebeaMitsumi Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014252644	C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042344	Aesculap, Inc.	EXCIA TOTAL HIP SYSTEM	2005-03-16
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
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-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1836357. Last updated year: 2026. Please use registration number 1836357 when referencing this establishment in official correspondence.