FDA.reportPublic FDA data

ASPHERE

Primary DI
10603295033011
Brand
ASPHERE
Company
DEPUY (IRELAND)
Model
1365-07-100
Catalog number
136507100
Device description
ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +8.5 OFFSET
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
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)Orthopedic3
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082585000DEPUY ASPHERE M-SPEC HEADDePuy Orthopaedics, Inc.2008-12-04KWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295033011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329503301110603295033011

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295033141S-ROM1365-16-5001365165002015-09-24
10603295033158S-ROM1365-17-5001365175002015-09-24
10603295033165S-ROM1365-18-5001365185002015-09-24
10603295033738S-ROM1365-41-5001365415002015-09-24
10603295033752S-ROM1365-42-5001365425002015-09-24
10603295033776S-ROM1365-43-5001365435002015-09-24
10603295033790S-ROM1365-44-5001365445002015-09-24
10603295033851S-ROM1365-45-5001365455002015-09-24
10603295033875S-ROM1365-47-5001365475002015-09-24
10603295034056S-ROM1365-61-5001365615002015-09-24
10603295034094S-ROM1365-62-5001365625002015-09-24
10603295034131S-ROM1365-63-5001365635002015-09-24
10603295034179S-ROM1365-64-5001365645002015-09-24
10603295034216S-ROM1365-65-5001365655002015-09-24
10603295034230S-ROM1365-66-5001365665002015-09-24
10603295170778S-ROM52-20225220222015-09-24
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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09348215185701Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185718Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
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09348215185749Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185756Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185763Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185770Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
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