FDA.reportPublic FDA data

KangLi Pedicle Screw Spinal System

Primary DI
06937762171331
Brand
KangLi Pedicle Screw Spinal System
Company
Suzhou Kangli Orthopaedics Instrument Co.,Ltd.
Model
T5815535
Catalog number
T5815535
Device description
KSS 6.0 U-Pedicle Screw φ5.5×35mm
Published
2016-09-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142290000KangLi pedical screw spinal systemSuzhou Kangli Orthopaedics Instrument Co., Ltd.2014-11-24MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937762171331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937762171331069377621713316937762171331

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length35Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
527054774
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937762166474KangLi Locking Plates SystemT4071006T40710062016-09-03
06937762166481KangLi Locking Plates SystemT4071007T40710072016-09-03
06937762166498KangLi Locking Plates SystemT4071008T40710082016-09-03
06937762166504KangLi Locking Plates SystemT4071009T40710092016-09-03
06937762166511KangLi Locking Plates SystemT4071010T40710102016-09-03
06937762166535KangLi Locking Plates SystemT4071012T40710122016-09-03
06937762166559KangLi Locking Plates SystemT4071014T40710142016-09-03
06937762178033KangLi Locking Plates SystemT4071016T40710162016-09-03
06937762171348KangLi Pedicle Screw Spinal SystemT5815540T58155402016-09-03
06937762171355KangLi Pedicle Screw Spinal SystemT5816035T58160352016-09-03
06937762171362KangLi Pedicle Screw Spinal SystemT5816040T58160402016-09-03
06937762171379KangLi Pedicle Screw Spinal SystemT5816045T58160452016-09-03
06937762171386KangLi Pedicle Screw Spinal SystemT5816050T58160502016-09-03
06937762171393KangLi Pedicle Screw Spinal SystemT5816535T58165352016-09-03
06937762171409KangLi Pedicle Screw Spinal SystemT5816540T58165402016-09-03
06937762171416KangLi Pedicle Screw Spinal SystemT5816545T58165452016-09-03
06937762171423KangLi Pedicle Screw Spinal SystemT5816550T58165502016-09-03
06937762171430KangLi Pedicle Screw Spinal SystemT5817035T58170352016-09-03
06937762171447KangLi Pedicle Screw Spinal SystemT5817040T58170402016-09-03
06937762171492KangLi Pedicle Screw Spinal SystemT5825535T58255352016-09-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24
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