FDA.reportPublic FDA data

Syntec-Taichung Non-sterile Bone Plate and Screw Implants

Primary DI
04719864661314
Brand
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
Company
SYNTEC SCIENTIFIC CORPORATION
Model
211028
Device description
Cortex Screw φ2.0 x 28 mm
Published
2023-06-16
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983495000SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420Syntec Scientific Corp.1998-12-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719864661314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719864661314047198646613144719864661314

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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
04719864684009Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413702413702026-02-05
04719864684078Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420502420502026-02-05
04719864684085Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420602420602026-02-05

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