FDA.reportPublic FDA data

SUMMIT

Primary DI
10603295059530
Brand
SUMMIT
Company
DEPUY ORTHOPAEDICS, INC.
Model
1570-03-090
Catalog number
157003090
Device description
SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 3 STD 108mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295059530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329505953010603295059530

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
080506581
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295562108VELYS Hip Navigation4515801514515801512026-03-24
10603295553625ATTUNE2999-67-0322999670322026-02-17
10603295553632ATTUNE2999-67-0332999670332026-02-17
10603295553649ATTUNE2999-67-0342999670342026-02-17
10603295553656ATTUNE2999-67-0352999670352026-02-17
10603295554974EMPHASYS2999-67-0462999670462026-02-04
10603295080121AML EXCEL2001-65-0002001650002018-06-15
10603295082408DURALOC2015-24-0002015240002018-09-24
10603295083382SIGMA2024-57-1112024571112018-09-24
10603295084075SIGMA2024-85-0052024850052018-09-24
10603295088042GLOBAL FX2128-01-0222128010222018-09-24
10603295090540GLOBAL AP2130-01-0552130010552018-09-24
10603295090687GLOBAL AP2130-04-0002130040002018-09-24
10603295094005NA2178-30-1222178301222018-09-24
10603295095651LCS COMPLETION2178-60-0282178600282018-09-24
10603295096184NA2178-63-1242178631242018-09-24
10603295096191NA2178-63-1262178631262018-09-24
10603295098935PINNACLE2217-50-0042217500042018-09-24
10603295098942PINNACLE2217-50-0052217500052018-09-24
10603295098959PINNACLE2217-50-0062217500062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844693367implaFit®implantcast GmbHLZO2026-03-26
04048844693411implaFit®implantcast GmbHLZO2026-03-26
04048844693442implaFit®implantcast GmbHLZO2026-03-26
04048844693510implaFit®implantcast GmbHLZO2026-03-26
04048844693565implaFit®implantcast GmbHLZO2026-03-26
04048844693596implaFit®implantcast GmbHLZO2026-03-26
04048844731977implaFit®implantcast GmbHLZO2026-03-20
04048844732042implaFit®implantcast GmbHLZO2026-03-20
04048844732059implaFit®implantcast GmbHLZO2026-03-20
04048844732080implaFit®implantcast GmbHLZO2026-03-20
04048844732097implaFit®implantcast GmbHLZO2026-03-20
10885862660145N/AExactech, Inc.LZO2026-03-19
10885862660152N/AExactech, Inc.LZO2026-03-19
10885862660169N/AExactech, Inc.LZO2026-03-19
10885862660176N/AExactech, Inc.LZO2026-03-19
10885862660183N/AExactech, Inc.LZO2026-03-19
10885862660190N/AExactech, Inc.LZO2026-03-19
10885862660206N/AExactech, Inc.LZO2026-03-19
10885862660213N/AExactech, Inc.LZO2026-03-19
10885862660220N/AExactech, Inc.LZO2026-03-19
10885862660237N/AExactech, Inc.LZO2026-03-19
10885862660244N/AExactech, Inc.LZO2026-03-19
10885862660251N/AExactech, Inc.LZO2026-03-19
10885862660268N/AExactech, Inc.LZO2026-03-19
10885862660275N/AExactech, Inc.LZO2026-03-19
10885862660282N/AExactech, Inc.LZO2026-03-19
10885862660299N/AExactech, Inc.LZO2026-03-19
10885862660305N/AExactech, Inc.LZO2026-03-19
10885862660312N/AExactech, Inc.LZO2026-03-19
10885862660329N/AExactech, Inc.LZO2026-03-19