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Ruthless Spine RJB - Case

FDA UDI

Class II (US FDA UDI)

by Ruthless Spine

Identity

Trade Name
Ruthless Spine RJB - Case FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
RJB Device (case) FDA UDI
Model / Reference
RJB6-Case FDA UDI
Description
RJB Device (case) FDA UDI

Identifiers

Primary DI / UDI-DI
G492RJB61 FDA UDI
510(k) Number
DEN230012 FDA UDI
FDA Product Code
QWL FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Ruthless Spine RJB - Case by Ruthless Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

DEN230012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ruthless Spine

Sources (1)

  • FDA UDI 31ea4d4c-bf83-47fe-a60c-4fcb3f59a073 35 fields · synced Jun 8, 2026