FDA.reportPublic FDA data

S-ROM

Primary DI
10603295178170
Brand
S-ROM
Company
DEPUY ORTHOPAEDICS, INC.
Model
56-3216R
Catalog number
563216R
Device description
S-ROM Total Hip System FEMORAL STEM Right Long 30 STD NECK +4 11/13 TAPER 16x11x205 Lateral
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910664000MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.Medimix Products, Inc.1992-04-01LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295178170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329517817010603295178170

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14