FDA.reportPublic FDA data

NA

Primary DI
10603295032687
Brand
NA
Company
DEPUY ORTHOPAEDICS, INC.
Model
1363-12-000
Catalog number
136312000
Device description
MODULAR CATHCART TAPERED SPACER 12/14 TAPER +5mm
Published
2015-09-24
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
LZYProsthesis, hip, hemi-, femoral, metal ball

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZYProsthesis, Hip, Hemi-, Femoral, Metal BallOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903084000MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.1990-10-03LZY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295032687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329503268710603295032687

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head/stem prosthesis adaptorA sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.

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
07630030804342AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630030804359AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630030804458AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630040719988AMIStem-PMedacta International SALZY2021-10-22
07630040719995AMIStem-PMedacta International SALZY2021-10-22
07630040720007AMIStem-PMedacta International SALZY2021-10-22
07630040720014AMIStem-PMedacta International SALZY2021-10-22
07630040720021AMIStem-PMedacta International SALZY2021-10-22
07630040720038AMIStem-PMedacta International SALZY2021-10-22
07630040720045AMIStem-PMedacta International SALZY2021-10-22
07630040720052AMIStem-PMedacta International SALZY2021-10-22
07630040720069AMIStem-PMedacta International SALZY2021-10-22
07630040720076AMIStem-PMedacta International SALZY2021-10-22
07630040720083AMIStem-PMedacta International SALZY2021-10-22
07630040720090AMIStem-PMedacta International SALZY2021-10-22
07630040720106AMIStem-PMedacta International SALZY2021-10-22
07630040720113AMIStem-PMedacta International SALZY2021-10-22
07630040720120AMIStem-PMedacta International SALZY2021-10-22
07630040720137AMIStem-PMedacta International SALZY2021-10-22
07630040720144AMIStem-PMedacta International SALZY2021-10-22
07630040720151AMIStem-PMedacta International SALZY2021-10-22
07630040720168AMIStem-PMedacta International SALZY2021-10-22
07630040720175AMIStem-PMedacta International SALZY2021-10-22
07630040720182AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720199AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720205AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720212AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720229AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720236AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720243AMIStem-P CollaredMedacta International SALZY2021-10-22