FDA.report

Austin Moore

Primary DI
07613327140293
Brand
Austin Moore
Company
Howmedica Osteonics Corp.
Model
6939-1-480
Catalog number
6939-1-480
Device description
Hip Endoprosthesis
Published
2015-09-24
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
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications

CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613327140293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613327140293076133271402937613327140293

GMDN Terms

TermDefinition
Uncoated hip femur prosthesis, one-pieceA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
058311945
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08031497003979Interspace GV Hip Spacer 60TECRES SPAKWL2026-02-11
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08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAKWL2026-02-11
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