Healix

FDA UDI

Class II (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name: Healix FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: Washer 3.0-3.5mm. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine. FDA UDI
Model / Reference: CSRW-WASH-335 FDA UDI
Description: Washer 3.0-3.5mm. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810005662345 FDA UDI
510(k) Number: K182949 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 7.64 Millimeter FDA UDI

Category: Implantable bone washer

Healix by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable bone washer.

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Monster Screw System — Paragon 28 · Class II
ALPHALOK Plating System — Vilex, Inc. · Class II
Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · 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: Nvision Biomedical Technologies, Inc

Sources (1)

FDA UDI 571d4b95-4c93-4737-bd56-9e4b34ab11aa 36 fields · synced May 31, 2026