FDA.reportPublic FDA data

SOLCO 4CIS® General Plate System

Primary DI
08800313887983
Brand
SOLCO 4CIS® General Plate System
Company
ALPHA AI CO.,LTD.
Model
96-50810
Catalog number
96-50810
Device description
Reconstruction plates, Curved
Published
2026-04-21
Public version status
New
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051155000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051155000SOLCO 4CIS GENERAL PLATE SYSTEMSolco Biomedical Co., Ltd.2005-07-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800313887983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800313887983088003138879838800313887983

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
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
088003138872354CIS® Spinal System and 4CIS® Low Back System4142-70554142-70552026-04-15

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