FDA.reportPublic FDA data

Planar Reduction Screw

Primary DI
06912547395348
Brand
Planar Reduction Screw
Company
Shandong Weigao Orthopaedic Device Co., Ltd.
Model
803607525
Published
2017-12-12
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170861000PremierShandong Weigao Orthopaedic Device Co., Ltd.2017-08-04NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06912547395348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06912547395348069125473953486912547395348

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
06912547143659Iliac Screws8035370602016-07-05
06912547143666Iliac Screws8035370652016-07-15
06912547143673Iliac Screws8035370702016-07-15
06912547143680Iliac Screws8035370752016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157125325ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125332ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125349ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125356ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125363ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125370ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125387ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125394ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125400ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125417ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125424ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125448ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125455ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125462ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125479ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125486ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125493ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125509ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125516ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125523ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125530ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125547ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125554ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125561ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125578ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125585ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125592ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125608ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125615ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125622ZAVATION SCREWZavation LLCNKB2026-11-05