FDA.reportPublic FDA data

4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM

Primary DI
08806373594915
Brand
4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM
Company
ALPHA AI CO.,LTD.
Model
15-8642
Catalog number
15-8642
Device description
Defender® ST Fixed Self Drilling Screw ø4.35 X 22mm
Published
2023-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1824890004CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.2019-01-16KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373594915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373594915088063735949158806373594915

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08