Dymaxeon

FDA UDI

Class II (US FDA UDI)

by Back 2 Basic Direct, Llc

Identity

Trade Name: Dymaxeon FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: Vertebral Rod aligner FDA UDI
Model / Reference: 05.5 FDA UDI
Description: Vertebral Rod aligner FDA UDI

Identifiers

Catalog Number: 09.0674 FDA UDI
Primary DI / UDI-DI: 00815500025459 FDA UDI
FDA Product Code: NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool 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

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

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

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic fixation implant alignment tool

Dymaxeon by Back 2 Basic Direct, Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Back 2 Basic Direct, Llc

Sources (1)

FDA UDI 9d7e7d7d-6b13-4353-9a19-6c5bbd4442cf 35 fields · synced May 31, 2026