Quick Reduction Tool

Primary DI
07290115934526
Brand
Quick Reduction Tool
Company
PREMIA SPINE LTD
Model
86744
Published
2024-10-01
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150380000
K170061000
K182598000
K231844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150380000ProMIS Fixation SystemPremia Spine, Ltd.2015-07-17NKB
K170061000ProMIS™ Fixation SystemPremia Spine, Ltd.2017-02-02NKB
K182598000VersaLink™ Fixation SystemPremia Spine, Ltd.2018-11-13NKB
K231844000ProMIS™ Fixation SystemPremia Spine, Ltd.2023-07-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934526072901159345267290115934526

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-reduction toolA hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01
07290115935646Cannulated Screwdriver External sleeve Short882662026-06-01
07290115935653Cannulated Screwdriver Handle Assy XL872452026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XL871542026-06-01
07290115935837MIS Tower Guide86261N2026-06-01
07290014381254ProMIS™ Fixation System875112026-05-25
07290014381261ProMIS™ Fixation System875122026-05-25
07290115935615Counter Torque ST83142N2026-05-25
07290115932553VersaLink Bender825842024-10-01
07290115935479Rod Bender862972024-10-01
07290014381223SST 316 LVM, L=470, Ø1.5 over the K-Wire878512024-09-05
07290115934816K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA873022024-09-05
07290014381148SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill874472024-09-05
07290014381155SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique872092024-09-05
07290014381162SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire872082024-09-05

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