FDA.report

Ruthless Spine RJB

Primary DI
G492RJB60
Brand
Ruthless Spine RJB
Company
Ruthless Spine
Model
RJB6
Device description
RJB Device
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
QWLIntraoperative Surgical Angle Measurement Tool

Product Code Classifications

CodeDeviceSpecialtyClass
QWLIntraoperative Surgical Angle Measurement ToolOrthopedic2

Premarket Submissions

SubmissionSupplement
DEN230012000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230012000Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2023-07-14QWL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G492RJB60PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
855-496-3454info@ruthlessspine.com

Regulatory Flags

DUNS number
117227055
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G492RJBFLT10Ruthless Spine Duckbill Probe, PlasticRJB-FLT1RJBFLT12025-12-09
G492RJBMPV70810Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip 8 GaugeRJB-MPV7-081RJBMPV70812025-12-09
G492RJBMPV70820Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 GaugeRJB-MPV7-082RJBMPV70822025-12-09
G492RJBMPV71010Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip, 10 GaugeRJB-MPV7-101RJBMPV71012025-12-09
G492RJBMPV71020Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 10 GaugeRJB-MPV7-102RJBMPV71022025-12-09
G492RJBRCT10Ruthless Spine Ratchet Handle, PlasticRJB-RCT1RJBRCT12025-12-09
G492RJBSRP10Ruthless Spine Straight Probe, PlasticRJB-SRP1RJBSRP12025-12-09
G492RJBHND1R0Ruthless Spine Quick Connect Axial Ratcheting Handle, reusableRJB-HND1-RRJBHND1R2025-01-21
G492RJBPRB1R0Ruthless Spine Straight Probe, reusableRJB-PRB1-RRJBPRB1R2025-01-21
G492RJBPRB2R0Ruthless Spine Duckbill Probe, reusableRJB-PRB2-RRJBPRB2R2025-01-21
G492RJB61Ruthless Spine RJB - CaseRJB6-Case2024-01-29
G492RJBHND10Ruthless Spine Quick Connect Axial Ratcheting HandleRJB-HND12024-01-29
G492RJBPRB10Ruthless Spine Straight ProbeRJB-PRB12024-01-29
G492RJBPRB20Ruthless Spine Duckbill ProbeRJB-PRB22024-01-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G492RJBFLT10Ruthless Spine Duckbill Probe, PlasticRuthless SpineQWL2025-12-09
G492RJBMPV70810Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip 8 GaugeRuthless SpineQWL2025-12-09
G492RJBMPV70820Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 GaugeRuthless SpineQWL2025-12-09
G492RJBMPV71010Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip, 10 GaugeRuthless SpineQWL2025-12-09
G492RJBMPV71020Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 10 GaugeRuthless SpineQWL2025-12-09
G492RJBRCT10Ruthless Spine Ratchet Handle, PlasticRuthless SpineQWL2025-12-09
G492RJBSRP10Ruthless Spine Straight Probe, PlasticRuthless SpineQWL2025-12-09
G492RJBHND1R0Ruthless Spine Quick Connect Axial Ratcheting Handle, reusableRuthless SpineQWL2025-01-21
G492RJBPRB1R0Ruthless Spine Straight Probe, reusableRuthless SpineQWL2025-01-21
G492RJBPRB2R0Ruthless Spine Duckbill Probe, reusableRuthless SpineQWL2025-01-21
G492RJB61Ruthless Spine RJB - CaseRuthless SpineQWL2024-01-29
G492RJBHND10Ruthless Spine Quick Connect Axial Ratcheting HandleRuthless SpineQWL2024-01-29
G492RJBPRB10Ruthless Spine Straight ProbeRuthless SpineQWL2024-01-29
G492RJBPRB20Ruthless Spine Duckbill ProbeRuthless SpineQWL2024-01-29