FDA.reportPublic FDA data

Syntec-Taichung Non-sterile Bone Plate and Screw Implants

Primary DI
04719864684009
Brand
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
Company
SYNTEC SCIENTIFIC CORPORATION
Model
241370
Catalog number
241370
Device description
One-third Tubular Plate 3.5 x 7Holes x L88mm
Published
2026-02-05
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719864684009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719864684009047198646840094719864684009

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
657692971
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
04716873713751Syntec OS Spinal Fixation System8860088860082026-02-05
04719864661383Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020082020082026-02-05
04719864661390Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020102020102026-02-05
04719864661406Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020122020122026-02-05
04719864661413Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020142020142026-02-05
04719864661574Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040142040142026-02-05
04719864661581Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040162040162026-02-05
04719864661598Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040182040182026-02-05
04719864662830Syntec Osteo-plate and screw Fixation 2060142060142026-02-05
04719864662847Syntec Osteo-plate and screw Fixation 2060162060162026-02-05
04719864662854Syntec Osteo-plate and screw Fixation 2060182060182026-02-05
04719864679852Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2431602431602026-02-05
04719864679876Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413502413502026-02-05
04719864683736Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480502480502026-02-05
04719864683743Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480602480602026-02-05
04719864683750Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480702480702026-02-05
04719864683996Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413602413602026-02-05
04719864684078Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420502420502026-02-05
04719864684085Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420602420602026-02-05
04719864684092Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420702420702026-02-05

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