FDA.report

Modular Unipolar

Primary DI
10840843100799
Brand
Modular Unipolar
Company
Stelkast Incorporated
Model
SC1401-61XS
Device description
Unipolar Femoral Head
Published
2015-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code Classifications

CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840843100799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084084310079910840843100799

GMDN Terms

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

Regulatory Flags

DUNS number
804792265
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10840843100157Provident Hip SystemSC1217-462015-03-03
10840843100164Provident Hip SystemSC1217-482015-04-15
10840843100171Provident Hip SystemSC1217-502015-04-15
10840843100188Provident Hip SystemSC1217-522015-04-15
10840843100195Provident Hip SystemSC1217-542015-04-15
10840843100201Provident Hip SystemSC1217-562015-04-15
10840843100218Provident Hip SystemSC1217-582015-04-15
10840843100225Provident Hip SystemSC1217-602015-04-15
10840843100232Provident Hip SystemSC1217-622015-04-15
10840843100249Provident Hip SystemSC1217-642015-04-15
10840843100256Provident Hip SystemSC1217-662015-04-15
10840843100263Provident Hip SystemSC1217-682015-04-15
10840843100270Provident Hip SystemSC1217-702015-04-15
10840843100287Provident Hip SystemSC1217-722015-04-15
10840843100805Zirconia Ceramic HeadSC1405-28mm +0M2015-10-07
10840843100812Zirconia Ceramic HeadSC1405-28mm +3.5 L2015-10-07
10840843100829Zirconia Ceramic HeadSC1405-28mm -3.5 S2015-10-07
10840843100836Zirconia Ceramic HeadSC1406-28mm +7 XL2015-10-07
10840843100843Proform Hip SystemSC1408-100-462015-02-17
10840843100850Proform Hip SystemSC1408-100-482015-02-17

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