FDA.reportPublic FDA data

SpineNet SSP®

Primary DI
B047FB42140
Brand
SpineNet SSP®
Company
SPINENET, LLC
Model
SSP® Fixed Screw
Catalog number
FB4214
Device description
SpineNet SSP®, Fixed Screw, Blunt, 4.25x14mm
Published
2021-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B047FB42140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
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
B047106100SpineNet SSP®SpineNet SSP® Cam Torque Lmtr Handle106-102022-01-12
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
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05