FDA.reportPublic FDA data

Swedge Pedicle Screw Fixation System

Primary DI
B51521380
Brand
Swedge Pedicle Screw Fixation System
Company
SPINAL RESOURCES, INC.
Model
2-138
Device description
MIS Screw Tab Breaker
Published
2018-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170045000Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.2017-06-26NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B51521380PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
018255727
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B515LC020Locking Cap (Set Screw)LC-022026-05-15
B515NCRTT475550060Swedge Rod, Hyper-Lordotic Curved, TransitionNCRTT47555-0602026-05-15
B515NCRTT475550070Swedge Rod, Hyper-Lordotic Curved, TransitionNCRTT47555-0702026-05-15
B515NCRTT475550080Swedge Rod, Hyper-Lordotic Curved, TransitionNCRTT47555-0802026-05-15
B515NCRTT475550090Swedge Rod, Hyper-Lordotic Curved, TransitionNCRTT47555-0902026-05-15
B515NCRTT475550100Swedge Rod, Hyper-Lordotic Curved, TransitionNCRTT47555-1002026-05-15
B515RMCT55065Swedge Rod, MIS, CurvedRMCT55-652026-05-15
B515RSCT55045Swedge RodRSCT55-452026-05-15
B515RSCT55050Swedge RodRSCT55-502026-05-15
B515RSCT600500Swedge RodRSCT60-5002026-05-15
B515RSCTT475550040Swedge RodRSCTT47555-0402026-05-15
B515RSCTT475550045Swedge RodRSCTT47555-0452026-05-15
B515RSCTT475550050Swedge RodRSCTT47555-0502026-05-15
B515RSCTT475550120Swedge RodRSCTT47555-1202026-05-15
B515RSCTT475550150Swedge RodRSCTT47555-1502026-05-15
B515RSCTT475550200Swedge RodRSCTT47555-2002026-05-15
B515RSCTT475550250Swedge RodRSCTT47555-2502026-05-15
B515RSCTT475550300Swedge RodRSCTT47555-3002026-05-15
B515RSCTT50550045Swedge RodRSCTT5055-0452026-05-15
B515RSCTT50550050Swedge RodRSCTT5055-0502026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28