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Minimally Invasive Spine Surgery Instruments

FDA UDI

Class II (US FDA UDI)

by Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Identity

Trade Name
Minimally Invasive Spine Surgery Instruments FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Model / Reference
MSI-02 FDA UDI

Identifiers

Primary DI / UDI-DI
14719878713099 FDA UDI
FDA Product Code
SBF FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical planning/navigation-enhancement system

Minimally Invasive Spine Surgery Instruments by Taiwan Main Orthopaedic Biotechnology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Sources (1)

  • FDA UDI 4e5b3bae-bbd8-4c7e-854f-12ade8a6556a 32 fields · synced Jun 6, 2026