Iliac Screws

Primary DI
06912547143659
Brand
Iliac Screws
Company
Shandong Weigao Orthopaedic Device Co., Ltd.
Model
803537060
Published
2016-07-05
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
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160320000PremierShandong Weigao Orthopaedic Device Co., Ltd.2016-04-01MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06912547143659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06912547143659069125471436596912547143659

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
545249039
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06912547395195Planar Reduction Screw8036065402017-12-12
06912547395331Planar Reduction Screw8036070652017-12-12
06939488331211Multi-Axial Reduction Screw82265352016-07-07
06939488332201Planar Screw82645262016-07-15
06912547086260Multi-Axial Screw82145202016-07-05
06912547086284Multi-Axial Reduction Screw82245202016-07-05
06912547086307Fixed-Angle Screw82345202016-07-05
06912547086321Fixed-Angle Reduction Screw82445202016-07-05
06912547086345Planar Screw82645202016-07-05
06912547134787Planar Screw82665412016-07-15
06912547134794Planar Screw82665462016-07-15
06912547134800Planar Screw82675362016-07-15
06912547138273Set Screw84225002016-07-15
06912547142669Lateral Connector5.5 84260052016-07-15
06912547142676Domino Connector 5.5/5.584400082016-07-15
06912547142690Domino Connector 5.5/5.584408082016-07-15
06912547143666Iliac Screws8035370652016-07-15
06912547143673Iliac Screws8035370702016-07-15
06912547143680Iliac Screws8035370752016-07-15
06912547143697Iliac Screws8035375652016-07-15

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Primary DI, Brand, Company table
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00840466901622PrimusSPINAL ELEMENTS, INC.KWP2026-07-21