← Back to catalogue

Galaxy MIS Screw System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K143110

by Bm Korea

Identity

Trade Name
Galaxy Mis Screw System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. FDA UDI
Model / Reference
GC300-5550 FDA UDI
Description
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. FDA UDI

Identifiers

Primary DI / UDI-DI
08809255540437 FDA UDI
510(k) Number
K143110 FDA 510(k)FDA UDI
FDA Product Code
NKB FDA 510(k)FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 5.5 Millimeter FDA UDI
Length — 50 Millimeter FDA UDI

The Galaxy MIS Screw System is a minimally invasive spinal fixation device designed for posterior rod and screw fixation in orthopedic surgery. It employs a transmuscular approach and subfascial rod insertion to reduce soft tissue trauma, facilitating secure vertebral stabilization with reduced surgical disruption.

This system is supplied as a reusable orthopedic implant and is intended for use in operating room settings. The screws feature an all-in-one connected reduction sleeve, and the device is authorized under FDA 510(k) clearance (K143110) for orthopedic applications. Sterility and sizing details are not specified in the provided data.

Frequently asked questions

What types of surgical procedures is the Galaxy MIS Screw System designed for, and how does it reduce patient trauma during surgery?

The Galaxy MIS Screw System is designed for posterior rod and screw fixation in orthopedic spinal surgery, specifically using a minimally invasive (MIS) transmuscular approach and subfascial rod insertion. This approach minimizes soft tissue disruption, reducing trauma to surrounding muscles and tissues compared to traditional open surgery methods.

Is the Galaxy MIS Screw System intended for single-use or reusable applications, and where is it typically used?

The Galaxy MIS Screw System is supplied as a reusable orthopedic implant, meaning it is intended for use in multiple surgical procedures within an operating room setting. Its design and construction support repeated sterilization and application in controlled clinical environments.

How does the screw design of the Galaxy MIS Screw System contribute to its functionality in spinal stabilization?

The screws in the Galaxy MIS Screw System include an all-in-one connected reduction sleeve, which likely streamlines the surgical process by simplifying the alignment and fixation of rods to vertebrae. This feature helps ensure secure vertebral stabilization while reducing the complexity of manual adjustments during implantation.

What regulatory pathway was followed for the FDA clearance of the Galaxy MIS Screw System, and what does this mean for its clinical use?

The Galaxy MIS Screw System received FDA clearance through a Traditional 510(k) pathway (K143110) under the Orthopedic (OR) advisory committee, with a decision labeled as *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device for orthopedic spinal fixation applications, allowing its use in clinical settings where minimally invasive stabilization is indicated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Galaxy MIS - SPINEMarketGroup, Products | 비엠코리아, GALAXY Minimally Invasive Spine Screw Fixation - BM Korea - PDF ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Bm Korea

Sources (2)

  • FDA 510(k) K143110 24 fields · synced Sep 19, 2026
  • FDA UDI 15279362-abd6-438a-a9d2-c1d5c12dbeb5 35 fields · synced May 26, 2026