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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 connector FDA UDI
Device Name
Republic Spine Crosslink 65-80mm FDA UDI
Model / Reference
100012-0004 FDA UDI
Description
Republic Spine Crosslink 65-80mm FDA UDI

Identifiers

Catalog Number
DSCL-6580 FDA UDI
Primary DI / UDI-DI
B0751000120040 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Bone-screw internal spinal fixation system connector

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

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Republic Spine, LLC

Sources (1)

  • FDA UDI 8b00a5b6-b983-4f9c-9fc8-772f88c420e3 36 fields · synced Jun 1, 2026