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Ruthless Spine RJB

FDA UDI

Class II (US FDA UDI)

by Ruthless Spine

Identity

Trade Name
Ruthless Spine RJB FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
RJB Device FDA UDI
Model / Reference
RJB6 FDA UDI
Description
RJB Device FDA UDI

Identifiers

Primary DI / UDI-DI
G492RJB60 FDA UDI
510(k) Number
DEN230012 FDA UDI
FDA Product Code
QWL FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use 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 prosthesis implantation positioning instrument, single-use

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

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

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 fb3e05ec-6b28-4076-b907-4e83330e6ba8 35 fields · synced Jun 6, 2026