Dark Star Deformity

FDA UDI

Class II (US FDA UDI)

by Republic Spine, LLC

Identity

Trade Name: Dark Star Deformity FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: MIS Straight Rod - Ø5.5mm x 50mm FDA UDI
Model / Reference: 100136-050 FDA UDI
Description: MIS Straight Rod - Ø5.5mm x 50mm FDA UDI

Identifiers

Catalog Number: DS-4050 FDA UDI
Primary DI / UDI-DI: B0751001360500 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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 Unsafe FDA UDI

Dimensions & Sizes

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

Category: Bone-screw internal spinal fixation system rod

Dark Star Deformity by Republic Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
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Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II

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: Republic Spine, LLC

Sources (1)

FDA UDI 38775ce5-913d-4b0d-8999-bb61b38cdca0 36 fields · synced May 30, 2026