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Mega Plus Spine System

FDA UDI

Class I (US FDA UDI)

by Bk Meditech Co., Ltd.

Identity

Trade Name
MEGA PLUS SPINE SYSTEM FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
Anti-Torque FDA UDI
Model / Reference
12200-10 FDA UDI
Description
Anti-Torque FDA UDI

Identifiers

Primary DI / UDI-DI
08809763499944 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

Mega Plus Spine System by Bk Meditech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bk Meditech Co., Ltd.

Sources (1)

  • FDA UDI d5735a6b-e6aa-4048-92c4-be34e1edc274 33 fields · synced May 31, 2026