FDA.reportPublic FDA data

S-ROM

Primary DI
10603295175995
Brand
S-ROM
Company
DEPUY ORTHOPAEDICS, INC.
Model
55-7099
Catalog number
557099
Device description
APICAL HOLE PLUG
Published
2014-09-20
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
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931676000S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUGJoint Medical Products Corp.1994-05-18JDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295175995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329517599510603295175995

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis hole plugA sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if opened or damaged.

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
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
10603295015543DURALOC1220-32-1541220321542015-09-24
10603295015550DURALOC1220-32-1561220321562015-09-24
10603295015567DURALOC1220-32-1581220321582015-09-24
10603295015574DURALOC1220-32-1601220321602015-09-24
10603295015581DURALOC1220-32-1621220321622015-09-24
10603295015598DURALOC1220-32-1641220321642015-09-24
10603295015604DURALOC1220-32-1661220321662015-09-24
10603295155010NA2841-10-0002841100002018-09-24
10603295552390ATTUNE2999-66-9712999669712026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286800570Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800587Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800594Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800600Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800617Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800624Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800631Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800648Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00880304498167Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304498174Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499065Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499072Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304452732TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452749TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452756TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
B27826000025E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
B27826000026E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
00880304652866COMPRESS® DEVICEBiomet Orthopedics, LLCJDL2016-04-01
00880304461604Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461611Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461628Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461635Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461642Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461659Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461666Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461673Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461680Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461697Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461703Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461765Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24