FDA.reportPublic FDA data

The JASPER Spinal Fixation System

Primary DI
08800033135623
Brand
The JASPER Spinal Fixation System
Company
GBS Commonwealth Co.,Ltd.
Model
L11E-80140
Published
2019-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173645000JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.2018-07-23NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800033135623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800033135623088000331356238800033135623

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
694609156
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
00880016731781Prase-C Anterior Cervical Plate SystemC117-17172021-10-31
08800167317827Prase-C Anterior Cervical Plate SystemC117-17182021-10-31
08800167314369Prase-C Anterior Cervical Plate SystemC128-42262021-09-30
08800167314376Prase-C Anterior Cervical Plate SystemC128-42252021-09-30
08800167314383Prase-C Anterior Cervical Plate SystemC128-42242021-09-30
08800167314390Prase-C Anterior Cervical Plate SystemC128-42232021-09-30
08800167314406Prase-C Anterior Cervical Plate SystemC128-42222021-09-30
08800167314413Prase-C Anterior Cervical Plate SystemC128-42212021-09-30
08800167314420Prase-C Anterior Cervical Plate SystemC128-42202021-09-30
08800167314437Prase-C Anterior Cervical Plate SystemC128-42192021-09-30
08800167314444Prase-C Anterior Cervical Plate SystemC128-42182021-09-30
08800167314451Prase-C Anterior Cervical Plate SystemC128-42172021-09-30
08800167314468Prase-C Anterior Cervical Plate SystemC128-42162021-09-30
08800167314475Prase-C Anterior Cervical Plate SystemC128-42152021-09-30
08800167314482Prase-C Anterior Cervical Plate SystemC128-42142021-09-30
08800167314499Prase-C Anterior Cervical Plate SystemC128-42132021-09-30
08800167314505Prase-C Anterior Cervical Plate SystemC128-42122021-09-30
08800167314512Prase-C Anterior Cervical Plate SystemC128-42112021-09-30
08800167314529Prase-C Anterior Cervical Plate SystemC128-42102021-09-30
08800167314536Prase-C Anterior Cervical Plate SystemC128-37262021-09-30

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