Salvo® Spine System

FDA UDI

Class I (US FDA UDI)

by Spine Wave, Inc.

Identity

Trade Name: Salvo® Spine System FDA UDI
Generic Name: Orthopaedic implantable-device cutter FDA UDI
Device Name: Bridge Cutter FDA UDI
Model / Reference: 10-5043 FDA UDI
Description: Bridge Cutter FDA UDI

Identifiers

Catalog Number: 10-5043 FDA UDI
Primary DI / UDI-DI: 10840642175691 FDA UDI
FDA Product Code: HTZ FDA UDI
GMDN Term: Orthopaedic implantable-device cutter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

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: Orthopaedic implantable-device cutter

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

Similar devices

Also classified as Orthopaedic implantable-device cutter.

Tecomet — Tecomet,Inc · Class I
General Instruments — ALPHATEC SPINE, INC. · Class I
PILLING — TELEFLEX INCORPORATED · Class I
Tecomet — Tecomet,Inc · Class I
BOLT/NUT SET — SONTEC INSTRUMENTS, INC. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
PLUG CUTTER — SONTEC INSTRUMENTS, INC. · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Spine Wave, Inc.

Sources (1)

FDA UDI ef9920e5-a3c0-4b23-9dda-44608455d248 35 fields · synced Jun 1, 2026