Helix

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: Helix FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: Helix ACP Screw, 4x11mm Fixed Self Tap FDA UDI
Model / Reference: 7734111 FDA UDI
Description: Helix ACP Screw, 4x11mm Fixed Self Tap FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517091291 FDA UDI
510(k) Number: K083341 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Category: Spinal fixation plate, non-bioabsorbable

Helix by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

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TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Rexious — Dio Medical Co., Ltd. · Class II

Cleared under the same submission

K083341 also covers:

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: Nuvasive, Inc.

Sources (1)

FDA UDI 8fe0859f-2d66-4216-9d8a-8f414ec4d3a6 35 fields · synced Jun 1, 2026