Spine Wave Instruments

FDA UDI

Class I (US FDA UDI)

by Spine Wave, Inc.

Identity

Trade Name: Spine Wave Instruments FDA UDI
Generic Name: Manual orthopaedic bender, reusable FDA UDI
Device Name: In Situ Bender, Left FDA UDI
Model / Reference: 10-8523.1 FDA UDI
Description: In Situ Bender, Left FDA UDI

Identifiers

Catalog Number: 10-8523.1 FDA UDI
Primary DI / UDI-DI: 10840642149814 FDA UDI
FDA Product Code: HXW FDA UDI
GMDN Term: Manual orthopaedic bender, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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: Manual orthopaedic bender, reusable

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

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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

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Manufacturer

Manufacturer: Spine Wave, Inc.

Sources (1)

FDA UDI 707a3c33-e9e2-4b4f-8632-80648253ab89 35 fields · synced Jun 1, 2026