UNIFLEX Fork Persuader

Primary DI
07290115935493
Brand
UNIFLEX Fork Persuader
Company
PREMIA SPINE LTD
Model
86603
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
07290115935493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115935493072901159354937290115935493

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05