FDA.reportPublic FDA data

Ruthless Spine Straight Probe, Plastic

Primary DI
G492RJBSRP10
Brand
Ruthless Spine Straight Probe, Plastic
Company
Ruthless Spine
Model
RJB-SRP1
Catalog number
RJBSRP1
Device description
RJB system instrument, Straight Probe, Plastic
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWLIntraoperative Surgical Angle Measurement Tool

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWLIntraoperative Surgical Angle Measurement ToolOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252615000Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2025-09-17QWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G492RJBSRP10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, single-useA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-496-3454info@ruthlessspine.com

Regulatory Flags#

DUNS number
117227055
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
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
G492RJB60Ruthless Spine RJBRJB62024-01-29
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 DI, Brand, Company table
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
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
G492RJB60Ruthless Spine RJBRuthless SpineQWL2024-01-29
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