Dark Star Deformity

FDA UDI

Class II (US FDA UDI)

by Republic Spine, LLC

Identity

Trade Name: Dark Star Deformity FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: Polyaxial Screw head positioner FDA UDI
Model / Reference: 100274 FDA UDI
Description: Polyaxial Screw head positioner FDA UDI

Identifiers

Catalog Number: DS0029 FDA UDI
Primary DI / UDI-DI: B0751002740 FDA UDI
FDA Product Code: KWP FDA UDI
NKB FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Category: Orthopaedic fixation implant alignment tool

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

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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 2b804acf-36ec-4dfc-81df-91a53f16e292 35 fields · synced Jun 1, 2026