FDA.reportPublic FDA data

Corin Metafix Hip Stem

Primary DI
05055196909236
Brand
Corin Metafix Hip Stem
Company
CORIN LTD
Model
340.300
Catalog number
340.300
Device description
Neck Resection Template
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082525000CORIN METAFIX FEMORAL STEMCorin USA2010-02-04LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055196909236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196909236050551969092365055196909236

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441285659866lucinda.gerber@coringroup.com
+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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139245374Apollo KneeCOR.TS.13002025-04-07
05056139247293Icona Hip Stem72611112025-04-07
05056139250644Apollo KneeTKR.KT.13002025-04-07
05056139244933Apollo KneeTKR.BB.14022025-04-07
05056139244940Apollo KneeTKR.BB.14032025-04-07
05056139244971Apollo KneeTKR.IN.16002025-04-07
05056139244988Apollo KneeTKR.IN.17002025-04-07
05056139244995Apollo KneeTKR.BB.17002025-04-07
05056139245008Apollo KneeTKR.BB.17012025-04-07
05056139245015Apollo KneeTKR.BB.17022025-04-07
05056139245022Apollo KneeTKR.BB.17032025-04-07
05056139245039Apollo KneeTKR.BB.17042025-04-07
05056139245053Apollo KneeTKR.BB.17052025-04-07
05056139245060Apollo KneeTKR.BB.17062025-04-07
05056139245077Apollo KneeTKR.BB.17072025-04-07
05056139245145Apollo KneeTKR.IN.18002025-04-07
05056139245176Apollo KneeTKR.BB.15002025-04-07
05056139245718Apollo KneeTKR.IN.14002025-04-07
05056139245770Apollo KneeTKR.BB.11002025-04-07
05056139245787Apollo KneeTKR.BB.11012025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022448NAExactech, Inc.JDI2022-09-19
10885862022455NAExactech, Inc.JDI2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.JDI2022-09-19
10885862034038NovationExactech, Inc.JDI2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.JDI2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.JDI2022-09-19
10885862034069NovationExactech, Inc.JDI2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.JDI2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19
10885862033598NovationExactech, Inc.LZO2022-08-25
10885862033598NovationExactech, Inc.JDI2022-08-25
10885862033604NovationExactech, Inc.JDI2022-08-25
10885862033604NovationExactech, Inc.LZO2022-08-25
10885862033611NovationExactech, Inc.JDI2022-08-25
10885862033611NovationExactech, Inc.LZO2022-08-25