Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014252644

FEI Number

3014252644

Entity Name

C&A Tool Engineering, Inc. Auburn Plant

City/State/Country

Auburn, IN, US

Establishment Address

1015 W 15th St, Auburn, IN 46706, 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

PERIMETER® Interbody Fusion Device SHILLA Growth Guidance System ANTERALIGN Spinal System with Titan nanoLOCK Surface Technology ELEOS Limb Salvage System with BioGrip INFINITY Navigated OCT System CD HORIZON® Spinal System 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 PRESTIGE® Cervical Disc System T2 ALTITUDE Expandable Corpectomy System CD HORIZON® SOLERA® VOYAGER Spinal System CD HORIZON® SOLERA® VOYAGER Spinal System BLUEPRINT PATIENT SPECIFIC INSTRUMENTATION T2 STRATOSPHERE Expandable Corpectomy System POWEREASE Instruments CD HORIZON® SOLERA® VOYAGER Spinal System CD Horizon Spinal System ANTERALIGN Spinal System with Titan nanoLOCK Surface Technology orthopedic manual surgical instrument PROSTALAC EXCEL T2 STRATOSPHERE Expandable Corpectomy System CD HORIZON® Spinal System CD HORIZON® Spinal System StageOne Select Hip Neck Length Adapter -6mm StageOne Select Hip Neck Length Adapter Standard Size StageOne Select Hip Neck Length Adapter +6mm instrument, manual, surgical, general use Echo FX RIALTO SI FUSION SYSTEM CD HORIZON® Spinal System INFINITY Navigated OCT System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-10-05
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2017-10-04
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
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2017-10-05
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-09-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-09-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-09-29
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	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
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2017-10-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-10-05
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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2026-03-04
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-03-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-05-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-09-29
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2017-10-05
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2019-10-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2019-10-03
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2019-10-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2026-01-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-12
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-12
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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-10-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-10-04
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-04-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-04-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-04-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-09-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-10-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-10-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-10-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-09-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-09-29
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-05-11
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2023-05-11
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2023-05-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-10-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-29

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
1836357	C+A TOOL ENGINEERING, INC.	Churubusco, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014252644. Last updated year: 2026. Please use registration number 3014252644 when referencing this establishment in official correspondence.