FDA.reportPublic FDA data

C2 Hip

Primary DI
08033390066624
Brand
C2 Hip
Company
LIMACORPORATE SPA
Model
9045.12.110
Catalog number
9045.12.110
Device description
C2 Hip - Broach # 9
Published
2021-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170473000C2 femoral stemLima Corporate S.P.A.2017-11-08LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390066624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390066624080333900666248033390066624

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390201858Smart SPACE SHOULDER0023.L1.N330023.L1.N332023-02-18
08033390201872Smart SPACE SHOULDER0023.L2.N330023.L2.N332023-02-18
08033390201896Smart SPACE SHOULDER0023.L3.N330023.L3.N332023-02-18
08033390201919Smart SPACE SHOULDER0023.R1.N330023.R1.N332023-02-18
08033390201933Smart SPACE SHOULDER0023.R2.N330023.R2.N332023-02-18
08033390201957Smart SPACE SHOULDER0023.R3.N330023.R3.N332023-02-18
08033390239509Smart SPACE SHOULDER0023.R4.N330023.R4.N332023-02-18
08033390239516Smart SPACE SHOULDER0023.L4.N330023.L4.N332023-02-18
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247293Icona Hip StemCORIN LTDKWY2025-04-07
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LWJ2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.LWJ2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.LWJ2022-09-19
10885862034052NovationExactech, Inc.LWJ2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LWJ2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.LWJ2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19
10885862034083NovationExactech, Inc.LWJ2022-09-19
10885862034090NovationExactech, Inc.LWJ2022-09-19
10885862034090NovationExactech, Inc.LZO2022-09-19
10885862034106NovationExactech, Inc.LWJ2022-09-19
10885862034106NovationExactech, Inc.LZO2022-09-19
10885862034113NovationExactech, Inc.LZO2022-09-19
10885862034113NovationExactech, Inc.LWJ2022-09-19
10885862033598NovationExactech, Inc.LZO2022-08-25
10885862033598NovationExactech, Inc.LWJ2022-08-25
10885862033604NovationExactech, Inc.LZO2022-08-25
10885862033604NovationExactech, Inc.LWJ2022-08-25
10885862033611NovationExactech, Inc.LZO2022-08-25
10885862033611NovationExactech, Inc.LWJ2022-08-25