FDA.reportPublic FDA data

Prase-C Anterior Cervical Plate System

Primary DI
08800167314444
Brand
Prase-C Anterior Cervical Plate System
Company
GBS Commonwealth Co.,Ltd.
Model
C128-4218
Published
2021-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211205000Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.2021-08-12KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800167314444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800167314444088001673144448800167314444

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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 typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694609156
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
00880016731781Prase-C Anterior Cervical Plate SystemC117-17172021-10-31
08800167317827Prase-C Anterior Cervical Plate SystemC117-17182021-10-31
08800167314369Prase-C Anterior Cervical Plate SystemC128-42262021-09-30
08800167314376Prase-C Anterior Cervical Plate SystemC128-42252021-09-30
08800167314383Prase-C Anterior Cervical Plate SystemC128-42242021-09-30
08800167314390Prase-C Anterior Cervical Plate SystemC128-42232021-09-30
08800167314406Prase-C Anterior Cervical Plate SystemC128-42222021-09-30
08800167314413Prase-C Anterior Cervical Plate SystemC128-42212021-09-30
08800167314420Prase-C Anterior Cervical Plate SystemC128-42202021-09-30
08800167314437Prase-C Anterior Cervical Plate SystemC128-42192021-09-30
08800167314451Prase-C Anterior Cervical Plate SystemC128-42172021-09-30
08800167314468Prase-C Anterior Cervical Plate SystemC128-42162021-09-30
08800167314475Prase-C Anterior Cervical Plate SystemC128-42152021-09-30
08800167314482Prase-C Anterior Cervical Plate SystemC128-42142021-09-30
08800167314499Prase-C Anterior Cervical Plate SystemC128-42132021-09-30
08800167314505Prase-C Anterior Cervical Plate SystemC128-42122021-09-30
08800167314512Prase-C Anterior Cervical Plate SystemC128-42112021-09-30
08800167314529Prase-C Anterior Cervical Plate SystemC128-42102021-09-30
08800167314536Prase-C Anterior Cervical Plate SystemC128-37262021-09-30
08800167314543Prase-C Anterior Cervical Plate SystemC128-37252021-09-30

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