FDA.reportPublic FDA data

4CIS® Chiron Spinal Fixation System

Primary DI
08800033333357
Brand
4CIS® Chiron Spinal Fixation System
Company
ALPHA AI CO.,LTD.
Model
4138-9525
Catalog number
4138-9525
Device description
4CIS® Chiron Poly Reduction Cannulated Screw Ø9.5 X 25mm (Rod Ø6.0)
Published
2020-06-06
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1904710004CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.2019-07-24NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800033333357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800033333357088000333333578800033333357

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
687844241
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
08800313887983SOLCO 4CIS® General Plate System96-5081096-508102026-04-21
088003138870444CIS® Spinal System and 4CIS® Low Back System62-4504562-450452026-04-15
088003138870514CIS® Spinal System and 4CIS® Low Back System62-5505062-550502026-04-15
088003138870684CIS® Spinal System and 4CIS® Low Back System62-6503062-650302026-04-15
088003138870754CIS® Spinal System and 4CIS® Low Back System62-6505562-650552026-04-15
088003138870824CIS® Spinal System and 4CIS® Low Back System62-7005062-700502026-04-15
088003138870994CIS® Spinal System and 4CIS® Low Back System62-7005562-700552026-04-15
088003138871054CIS® Spinal System and 4CIS® Low Back System62-7006062-700602026-04-15
088003138871124CIS® Spinal System and 4CIS® Low Back System62-1503062-150302026-04-15
088003138871294CIS® Spinal System and 4CIS® Low Back System62-1503562-150352026-04-15
088003138871364CIS® Spinal System and 4CIS® Low Back System62-1504062-150402026-04-15
088003138871434CIS® Spinal System and 4CIS® Low Back System62-1653062-165302026-04-15
088003138871504CIS® Spinal System and 4CIS® Low Back System62-1655062-165502026-04-15
088003138871674CIS® Spinal System and 4CIS® Low Back System62-1703062-170302026-04-15
088003138871744CIS® Spinal System and 4CIS® Low Back System62-1803562-180352026-04-15
088003138871814CIS® Spinal System and 4CIS® Low Back System62-1804062-180402026-04-15
088003138871984CIS® Spinal System and 4CIS® Low Back System62-1804562-180452026-04-15
088003138872044CIS® Spinal System and 4CIS® Low Back System4142-55504142-55502026-04-15
088003138872114CIS® Spinal System and 4CIS® Low Back System4142-65304142-65302026-04-15
088003138872284CIS® Spinal System and 4CIS® Low Back System4142-70504142-70502026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157059521ZAVATION RODZavation LLCNKB2026-06-04
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00197157059552ZAVATION RODZavation LLCNKB2026-06-04
00197157059569ZAVATION RODZavation LLCNKB2026-06-04
00197157059576ZAVATION RODZavation LLCNKB2026-06-04
00197157059583ZAVATION RODZavation LLCNKB2026-06-04
00197157059590ZAVATION RODZavation LLCNKB2026-06-04
00197157059606ZAVATION RODZavation LLCNKB2026-06-04
00197157059613ZAVATION RODZavation LLCNKB2026-06-04
00197157059620ZAVATION RODZavation LLCNKB2026-06-04
00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
00197157059491ZAVATION RODZavation LLCNKB2026-06-03
00197157059507ZAVATION RODZavation LLCNKB2026-06-03
00197157059514ZAVATION RODZavation LLCNKB2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03