FDA.reportPublic FDA data

TaperFit Cemented Hip System

Primary DI
05055343892503
Brand
TaperFit Cemented Hip System
Company
CORIN LTD
Model
588.6383
Catalog number
588.6383
Device description
Size 3 38mm Offset Rasp
Published
2018-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDGProsthesis, hip, femoral component, cemented, metal
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142761000Corin TaperFit Hip StemCorin USA2015-04-03JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055343892503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055343892503050553438925035055343892503

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441285659866rachel.king@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

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05056139247934Unity Total Knee System112621611262162026-10-19
05056139247996Unity Total Knee System112631011263102026-10-19
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05056139248023Unity Total Knee System112631411263142026-10-19
05056139248030Unity Total Knee System112631611263162026-10-19
05056139248092Unity Total Knee System112641011264102026-10-19
05056139248108Unity Total Knee System112641111264112026-10-19

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