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ECA MEDICAL INSTRUMENTS

United States·US-MF-000010686

Last updated September 17, 2026

About

ECA Medical Instruments is the world's \#1 provider of medical-grade torque limiters and Surgery-Ready procedural kits for orthopedic, spine, cardiovascular, and neuromodulation surgical procedures. FDA Registered, ISO 13485 certified, CGMP compliant, with 46 patents and 53 million+ instruments shipped worldwide.

From the manufacturer's own website. Source

Information

Country
United States
Address
1107, Tourmaline Drive, Newbury Park, United States
LinkedIn
—
Facebook
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Phone
+1 8053762509 ext 232
PRRC Contact
Janice Grace
EUDAMED SRN
US-MF-000010686
FDA FEI Number
3010052483
DUNS Number
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Catalogue (64)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Nx Nail Instrument Kit 3.0 mm
FDA UDI
Class IActive
Threaded Trimmable Fixation Nail Beveled Instrument Pack 967-005
FDA UDI
Class IActive
Orthopedic Cannulated Nail Instrument Pack 3.0 x 50mm 964-001
FDA UDI
Class IActive
Metacarpal Intramedullary Nail Surgery Ready Instrument Kit 1007
FDA UDI
Class IActive
Revcon Instrument Kit, Sterile 4.0MM
FDA UDI
Class IActive
ActivaScrew™ Cannulated Single-Use Instrument Kit (4.0MM) 1013-002
FDA UDI
Class IActive
2.4mm Volar Distal Radius Removal Driver 925 (AR-8924VD-S)
EUDAMEDFDA UDI
Class IIaActive
TruTORQ Large Engine Adaptor, 14 Nm 803-003
EUDAMEDFDA UDI
Class IIaActive
TruTORQ Small Engine, 0.5-2.0 Nm 801-001
EUDAMED
Class IIaActive
2.4mm Volar Distal Radius Instrument Kit 922 (AR-8924VIN-DS)
EUDAMEDFDA UDI
Class IIaActive
VariAX 2 Xpress Distal Radius Kit 991065S
EUDAMED
Class IIaActive
2.4mm Volar Distal Radius Trial Plates 926 (AR-8924VT-S)
EUDAMEDFDA UDI
Class IIaActive
TruTORQ Large Engine Adaptor, 12 Nm 803-002
EUDAMEDFDA UDI
Class IIaActive
TruTORQ Large Engine Adaptor, 7 Nm 803-001
EUDAMEDFDA UDI
Class IIaActive

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