FDA.reportPublic FDA data

Prase-C Anterior Cervical Plate System

Primary DI
08800167317575
Brand
Prase-C Anterior Cervical Plate System
Company
GBS Commonwealth Co.,Ltd.
Model
C111-1724
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
08800167317575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800167317575088001673175758800167317575

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
08800167314444Prase-C Anterior Cervical Plate SystemC128-42182021-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840019978453Reform TiPRECISION SPINE, INC.KWP2026-11-04
00840019978460Reform TiPRECISION SPINE, INC.KWP2026-11-04
00840019978477Reform TiPRECISION SPINE, INC.KWP2026-11-04
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWP2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809976AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809983AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809990AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03