FDA.reportPublic FDA data

Swedge Pedicle Screw Fixation System

Primary DI
B515PSST6545
Brand
Swedge Pedicle Screw Fixation System
Company
SPINAL RESOURCES, INC.
Model
PSST65-45
Device description
SCREW SPINE POLY STANDARD TITANIUM 06.5 X 45MM
Published
2024-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B515PSST6545PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
018255727
Device count
1
Lot or batch
true
Manufacturing date on label
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
B678520297S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520485S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520486S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520487S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520488S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520489S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520490S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520491S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520492S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520493S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520494S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520495S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520496S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02