Peridot Anterior Cervical Intervertebral Body Fusion System

Primary DI
08800113310063
Brand
Peridot Anterior Cervical Intervertebral Body Fusion System
Company
GBS Commonwealth Co.,Ltd.
Model
C247-1709
Published
2021-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202872000Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.2021-02-04ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800113310063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800113310063088001133100638800113310063

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

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