FDA.reportPublic FDA data

Humeral Cup Stability

Primary DI
03701037310519
Brand
Humeral Cup Stability
Company
FX SOLUTIONS
Model
314-0909
Catalog number
314-0909
Device description
HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9
Published
2020-05-20
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

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701037310519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037310519037010373105193701037310519

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263076196
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037303740HUMELOCK REVERSEDØ36/12 CEMENTLESS LOCKABLE317-36122017-01-31
03701037303092PRCT2100-0008100-00082016-06-08
03701037303108PRCT2100-0009100-00092016-06-08
03701037303115PRCT2100-0010100-00102016-06-08
03701037303139PRCT2100-0012100-00122016-06-08
03701037303160PRCT2100-0109100-01092016-06-08
03701037303177PRCT2100-0110100-01102016-06-08
03701037303184PRCT2100-0111100-01112016-06-08
03701037303191PRCT2100-0112100-01122016-06-08
03701037303207PRCT2100-0113100-01132016-06-08
03701037305843Humelock Reversed Shoulder903-0006903-00062018-09-27
03701037305850Humelock Reversed Shoulder903-0009-01903-0009-012018-09-27
03701037305867Humelock Reversed Shoulder903-0009-02903-0009-022018-09-27
03701037305911Humelock Reversed Shoulder903-0018903-00182018-09-27
03701037305782Humelock II Cemented Shoulder System902-0334902-03342018-09-27
03701037305799Humelock II Cemented Shoulder System902-0400902-04002018-09-27
03701037305805Humelock II Cemented Shoulder System902-0500902-05002018-09-27
03701037306406Humelock II Cemented Reversible Shoulder908-0055908-00552018-09-27
03701037311776Humelock II926-10412025-08-01
03701037311783Humelock II926-10422025-08-01

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Primary DI, Brand, Company table
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