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
- GC300-5590 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
- 08809255540512 FDA UDI
- 510(k) Number
- K143110 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile 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
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.5 Millimeter FDA UDILength — 90 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Galaxy Mis Screw System by Bm Korea Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K143110 also covers:
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
- Galaxy Mis Screw System — BM KOREA CO., LTD
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
- Bm Korea Co., Ltd
Sources (1)
- FDA UDI 844e2aef-cce9-47b9-b916-a7e4f025245b 35 fields · synced May 30, 2026