FDA.report

Swedge Pedicle Screw Fixation System

Primary DI
B515SPSST751100
Brand
Swedge Pedicle Screw Fixation System
Company
SPINAL RESOURCES, INC.
Model
SPSST75-110
Device description
Polyscrew, Standard, Solid, Titanium, 7.5mm x 110mm
Published
2018-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K170045000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B515SPSST751100PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
018255727
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B515RSTT47555450Swedge Pedicle Screw Fixation SystemRSTT47555-4502024-12-25
B515RSTT47555500Swedge Pedicle Screw Fixation SystemRSTT47555-5002024-12-25
B515RSTTC3005511Swedge Pedicle Screw Fixation SystemRSTTC-300-55112024-02-09
B515RSCTT47555120Swedge Pedicle Screw Fixation SystemRSCTT47555-1202024-07-29
B515RSCTT47555140Swedge Pedicle Screw Fixation SystemRSCTT47555-1402024-07-29
B515SPSCT6545Swedge Pedicle Screw Fixation SystemSPSCT65452024-07-29
B515SPSCT6550Swedge Pedicle Screw Fixation SystemSPSCT65502024-07-29
B515LC030Swedge Pedicle Screw Fixation SystemLC-032020-06-08
B515LC040Swedge Pedicle Screw Fixation SystemLC-042020-06-08
B515RSTT47555060Swedge Pedicle Screw Fixation SystemRSTT47555-0602024-02-09
B515RSTT47555070Swedge Pedicle Screw Fixation SystemRSTT47555-0702024-02-09
B515RSTT47555080Swedge Pedicle Screw Fixation SystemRSTT47555-0802024-02-09
B515RSTT47555090Swedge Pedicle Screw Fixation SystemRSTT47555-0902024-02-09
B515RSTT47555100Swedge Pedicle Screw Fixation SystemRSTT47555-1002024-02-09
B515RSTT47555120Swedge Pedicle Screw Fixation SystemRSTT47555-1202024-06-12
B515RSTT47555250Swedge Pedicle Screw Fixation SystemRSTT47555-2502024-06-12
B515RSCTT47555110Swedge Pedicle Screw Fixation SystemRSCTT47555-1102024-05-20
B515RSCTT47555130Swedge Pedicle Screw Fixation SystemRSCTT47555-1302024-05-20
B515RSCTT47555150Swedge Pedicle Screw Fixation SystemRSCTT47555-1502024-05-20
B515RSTT47555110Swedge Pedicle Screw Fixation SystemRSCTT47555-1102024-05-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465771Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465788Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465795Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465801Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465818Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465825Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465832Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465849Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465856Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465887Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22