Heli-FX™ EndoAnchor™ System

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Heli-FX™ EndoAnchor™ System FDA UDI
Generic Name: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name: ANCILLARY ENDOANCHOR CASSETTE US FDA UDI
Model / Reference: EC-05 FDA UDI
Description: ANCILLARY ENDOANCHOR CASSETTE US FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000006686 FDA UDI
510(k) Number: K171427 FDA UDI
K182957 FDA UDI
FDA Product Code: OTD FDA UDI
GMDN Term: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3460 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Soft-tissue/mesh anchor, non-bioabsorbable

Heli-FX™ EndoAnchor™ System by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Soft-tissue/mesh anchor, non-bioabsorbable.

MectaScrew PEEK — Medacta International · Class II
MectaFix CL Fixation Button with Continuous Loop — Medacta International · Class II
HNM MEDICAL — HNM STAINLESS, LLC. · Class II
MectaLock PEEK Suture Anchor — Medacta International · Class II
MectaScrew PEEK — Medacta International · Class II
Anchorsure — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI e2757f05-2b16-4e21-8979-a3f3667627e8 36 fields · synced May 30, 2026