Sniper® Spine System

FDA UDI

Class II (US FDA UDI)

by Spine Wave, Inc.

Identity

Trade Name: Sniper® Spine System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Rod, Curved, Co-Cr, 5.5 mm x 110 mm FDA UDI
Model / Reference: 11-4615 FDA UDI
Description: Rod, Curved, Co-Cr, 5.5 mm x 110 mm FDA UDI

Identifiers

Catalog Number: 11-4615 FDA UDI
Primary DI / UDI-DI: 10840642107470 FDA UDI
FDA Product Code: MNH FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 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 — 5.5 Millimeter FDA UDI
Length — 110 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

Sniper® Spine System by Spine Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Nex-D2 — Next Orthosurgical · Class II
CD HORIZON® SOLERA® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II

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: Spine Wave, Inc.

Sources (1)

FDA UDI d8c74c9e-7268-4af9-a301-6c0aaba9bc32 36 fields · synced Jun 8, 2026