FDA.reportPublic FDA data

S-ROM

Primary DI
10603295177715
Brand
S-ROM
Company
DEPUY ORTHOPAEDICS, INC.
Model
56-3060R
Catalog number
563060R
Device description
S-ROM Total Hip System FEMORAL STEM Right XXLong 36+21 CR NECK +8 11/13 TAPER 20x15x325 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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851422000S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIPJoint Medical Products Corp.1985-09-18JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295177715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329517771510603295177715

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
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
10603295015222DURALOC1220-28-1621220281622015-09-24
10603295015239DURALOC1220-28-1641220281642015-09-24
10603295015246DURALOC1220-28-1661220281662015-09-24
10603295015536DURALOC1220-32-1521220321522015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04046964680878COREHIP EXTENDEDAesculap AGLZO2020-08-10
04046964681028COREHIP EXTENDEDAesculap AGLZO2020-08-10
04046964681127COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681189COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681301COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681349COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681363COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681387COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681400COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681424COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681462COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681486COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681509COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681523COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681547COREHIP PRIMARYAesculap AGLZO2020-08-10
04546540035523OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LPH2015-09-24