FDA.reportPublic FDA data

SpineNet SSP®

Primary DI
B047106100
Brand
SpineNet SSP®
Company
SPINENET, LLC
Model
SpineNet SSP® Cam Torque Lmtr Handle
Catalog number
106-10
Device description
SpineNet SSP® Cam Torque Limiter Handle-Instrument
Published
2022-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200170000SpineNet SSP SystemSpinenet, LLC2020-02-05KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B047106100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
407-539-2483info@spinenetllc.com

Regulatory Flags#

DUNS number
792052321
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B047124110SpineNet SSP®SSP® Plate1-24112021-12-14
B047126130SpineNet SSP®SSP® Plate1-26132021-12-14
B047242290SpineNet SSP®SSP® Plate2-42292021-12-14
B047245320SpineNet SSP®SSP® Plate2-45322021-12-14
B047248350SpineNet SSP®SSP® Plate2-48352021-12-14
B047FB42120SpineNet SSP®SSP® Fixed ScrewFB42122021-12-14
B047FB42140SpineNet SSP®SSP® Fixed ScrewFB42142021-12-14
B047FB46120SpineNet SSP®SSP® Fixed ScrewFB46122021-12-14
B047FB46140SpineNet SSP®SSP® Fixed ScrewFB46142021-12-14
B047106010SpineNet SSP®SpineNet SSP® Bone Awl106-012022-01-12
B047106040SpineNet SSP®SpineNet SSP® Bone Tap106-042022-01-12
B047106060SpineNet SSP®SpineNet SSP® Small AO Chuck Handle106-062022-01-12
B047106070SpineNet SSP®SpineNet SSP® Fixed Drill Guide106-072022-01-12
B047106080SpineNet SSP®SpineNet SSP® Variable Drill Guide106-082022-01-12
B047106110SpineNet SSP®SpineNet SSP® Cam-Lock Driver106-112022-01-12
B047106120SpineNet SSP®SpineNet SSP® Plate Bender106-122022-01-12
B047106020SpineNet SSP®SSP® Drill Bit106-022021-12-13
B04710603120SpineNet SSP®SSP® Drill Sleeve, 12mm106-03-122021-12-13
B04710603140SpineNet SSP®SSP® Drill Sleeve, 14mm106-03-142021-12-13
B04710603160SpineNet SSP®SSP® Drill Sleeve, 16mm106-03-162021-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
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