FDA.reportPublic FDA data

Swedge Pedicle Screw Fixation System

Primary DI
B515SRI10010
Brand
Swedge Pedicle Screw Fixation System
Company
SPINAL RESOURCES, INC.
Model
SRI1001
Device description
Cross-Link Set Screw Driver
Published
2018-03-14
Public version status
Update
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
B515SRI10010PrimaryHIBCC0

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
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10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
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04546540147769XIA IIStryker CorporationNKB2014-12-08
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04546540147936XIA IStryker CorporationNKB2014-12-08
04546540147974XIA IStryker CorporationNKB2014-12-08
04546540147981XIA IStryker CorporationNKB2014-12-08
04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
04546540148025XIA IIStryker CorporationNKB2014-12-08
04546540148735XIA IIStryker CorporationNKB2014-12-08
04546540148742XIA IIStryker CorporationNKB2014-12-08
04546540148759XIA IIStryker CorporationNKB2014-12-08