Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010052483

FEI Number

3010052483

Entity Name

ECA MEDICAL INSTRUMENTS

City/State/Country

Newbury Park, CA, US

Establishment Address

1107 Tourmaline Drive, Newbury Park, CA 91320, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ECA Medical Instruments (Owner Number: 10042970)

Owner / Operator Contact Address

1107 Tourmaline Drive, Newbury Park, CA 91320, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

215-001 Axial Torque Driver 212 Axial Torque Driver Series 412 Fixed Driver 214 Axial Torque Driver Series 218-020 Torque Limiter 212-065 Axial Torque Driver 212-052 Axial Torque Driver 212-033 Axial Torque Driver 212-054 Axial Torque Driver 214-026 Axial Torque Driver 214-014 Axial Torque Driver 212-096 Axial Torque Driver 214-029 Axial Torque Driver 212-008C Axial Torque Driver 212-084 Axial Torque Driver 215-007 Axial Torque Driver 212-066 Axial Torque Driver 212-076 Axial Torque Driver 214-024 Axial Torque Driver 218-023 Torque Limiter 212-083 Axial Torque Driver 214-003 A Axial Torque Driver 212-042 Axial Torque Driver 212-037 Axial Torque Driver 212-019 Axial Torque Driver 212-011 Axial Torque Driver 212-081 Axial Torque Driver 214-030 Axial Torque Driver 212-050 Axial Torque Driver 214-031 Axial Torque Driver 212-045 Axial Torque Driver 214-012 Axial Torque Driver 212-061 Axial Torque Driver 212-082 Axial Torque Driver 212-102 Axial Torque Driver 212-048 Axial Torque Driver 212-093 Axial Torque Driver 214-032 Axial Torque Driver 212-100 Axial Torque Driver 218-029 Torque Limiter 212-032 Axial Torque Driver 212-029 Axial Torque Driver 212-069 Axial Torque Driver 212-043 Axial Torque Driver 212-007C Axial Torque Driver 212-056 Axial Torque Driver 212-079 Axial Torque Driver 212-047 Axial Torque Driver 212-087 Axial Torque Driver 212-051 Axial Torque Driver 214-008 Axial Torque Driver 212-046 Axial Torque Driver 212-030 Axial Torque Driver 212-058 Axial Torque Driver 212-040 Axial Torque Driver 212-041 Axial Torque Driver 214-028 Axial Torque Driver 212-094 Axial Torque Driver 212-053 Axial Torque Driver 212-021 Axial Torque Driver 218-031 Torque Limiter 212-090 Axial Torque Driver 214-023 Axial Torque Driver 212-063 Axial Torque Driver 212-085 Axial Torque Driver 214-022 Axial Torque Driver 212-057 Axial Torque Driver 212-016 Axial Torque Driver 212-013 Axial Torque Driver 212-038 Axial Torque Driver 212-039 Axial Torque Driver 212-105 Axial Torque Driver 218-022 Torque Limiter 214-006 B Axial Torque Driver 212-092 Axial Torque Driver 218-025 Torque Limiter 212-071 Axial Torque Driver 212-095 Axial Torque Driver 212-018 Axial Torque Driver 212-004C Axial Torque Driver 214-027 Axial Torque Driver 212-107 Axial Torque Driver 212-099 Axial Torque Driver 212-106 Axial Torque Driver 214-035 Axial Torque Driver 214-027 Axial Torque Driver 215 Axial Torque Driver Series 218 Torque Limiter Series 200-010-F Torque Limiter 212 Axial Torque Driver 214 Axial Torque Driver Series 207-012 Torque Limiter 207-014 Torque Limiter Hex Key Series 214-014 Axial Torque Driver 214-012 Axial Torque Driver 218-023 Torque Limiter 218-020 Torque Limiter 214-023 Axial Torque Driver 215-007 Axial Torque Driver 212-069 Axial Torque Driver 214-003 A Axial Torque Driver 212-079 Axial Torque Driver 100052-062 HEX Key 218-031 Torque Limiter 218-027 Torque Limiter 214-008 Axial Torque Driver 218-025 Torque Limiter 100934-001 Cap 100512-001 HEX Key 214-028 Axial Torque Driver 214-029 Axial Torque Driver 100148-002 HEX Key 215-001 Axial Torque Driver 214-002-A Axial Torque Driver 214-006 B Axial Torque Driver 214-033 Axial Torque Driver 214-015 Axial Torque Driver 219-TXAX-013 Torque Driver 214-026 Axial Torque Driver 218-029 Torque Limiter 100054-001 HEX Key 218-028 Torque Limiter 212-015C Axial Torque Driver 212-015C Axial Torque Driver

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2018-12-21
NWN	Laparoscopic Bone Anchor Urethropexy Instrument Kit	Orthopedic	Class 2	888.3040	2025-05-21
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2018-12-21
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-06-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-11-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-11-15
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2023-02-10
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-02-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-10-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-10-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-11-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-11-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-11
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2025-06-11
HXG	Tamp	Orthopedic	Class 1	888.4540	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-10-18
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2023-02-10
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2023-02-10
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2023-02-10

Official Correspondent

Janice Grace

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ECA Medical Instruments

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010052483. Last updated year: 2026. Please use registration number 3010052483 when referencing this establishment in official correspondence.