Dark Star Deformity

FDA UDI

Class II (US FDA UDI)

by Republic Spine, LLC

Identity

Trade Name: Dark Star Deformity FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Triple Lead Fine Pedicle Screw - Ø5.0mm x 45mm FDA UDI
Model / Reference: 101139-5045 FDA UDI
Description: Triple Lead Fine Pedicle Screw - Ø5.0mm x 45mm FDA UDI

Identifiers

Catalog Number: DSD3-5045 FDA UDI
Primary DI / UDI-DI: B07510113950450 FDA UDI
510(k) Number: K223096 FDA UDI
FDA Product Code: NKB FDA UDI
KWP FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable 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

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: Length — 45 Millimeter FDA UDI
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

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

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Also classified as Spinal bone screw, non-bioabsorbable.

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Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Cleared under the same submission

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 aa07578b-42ce-42fe-8c5d-6498cbd9eb2e 37 fields · synced May 31, 2026