FDA.report

The JASPER Spinal Fixation System

Primary DI
08800033150237
Brand
The JASPER Spinal Fixation System
Company
GBS Commonwealth Co.,Ltd.
Model
L132-0006
Published
2019-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800033150237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800033150237088000331502378800033150237

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694609156
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800033811107The JASPER Spinal Fixation SystemL219-55302019-08-23
08800033811114The JASPER Spinal Fixation SystemL219-55352019-08-23
08800033811121The JASPER Spinal Fixation SystemL219-55402019-08-23
08800033811138The JASPER Spinal Fixation SystemL219-55452019-08-23
08800033811145The JASPER Spinal Fixation SystemL219-55502019-08-23
08800033811152The JASPER Spinal Fixation SystemL219-55552019-08-23
08800033811169The JASPER Spinal Fixation SystemL219-55602019-08-23
08800033811176The JASPER Spinal Fixation SystemL219-60302019-08-23
08800033811183The JASPER Spinal Fixation SystemL219-60352019-08-23
08800033811190The JASPER Spinal Fixation SystemL219-60402019-08-23
08800033811206The JASPER Spinal Fixation SystemL219-60452019-08-23
08800033811213The JASPER Spinal Fixation SystemL219-60502019-08-23
08800033811220The JASPER Spinal Fixation SystemL219-60552019-08-23
08800033811237The JASPER Spinal Fixation SystemL219-60602019-08-23
08800033811244The JASPER Spinal Fixation SystemL219-65302019-08-23
08800033811251The JASPER Spinal Fixation SystemL219-65352019-08-23
08800033811268The JASPER Spinal Fixation SystemL219-65402019-08-23
08800033811275The JASPER Spinal Fixation SystemL219-65452019-08-23
08800033811282The JASPER Spinal Fixation SystemL219-65502019-08-23
08800033811299The JASPER Spinal Fixation SystemL219-65552019-08-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840493418704RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418711RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418728RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418735RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418742RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418759RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418766RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418773RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418780RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418797RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418803RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418810RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418827RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418834RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418841RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418858RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418865RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418872RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418889RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418896RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418902RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418919RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418926RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418933RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418940RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418957RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418964RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418971RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00190837124458ArxLife Spine, Inc.NKB2026-03-23
00190837124465ArxLife Spine, Inc.NKB2026-03-23