FDA.reportPublic FDA data

EXETER

Primary DI
04546540153289
Brand
EXETER
Company
Howmedica Osteonics Corp.
Model
0580-1-374
Catalog number
0580-1-374
Device description
V40 STEM
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

Product Codes#

Code, Name table
CodeName
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540153289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540153289045465401532894546540153289

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. 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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982648084ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
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00193982648527ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648619ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648626ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648688ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
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00193982648725ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648749ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648756ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648794ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648893ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648978ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649029ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649050ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649098ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649166ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649197ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649203ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649227ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
08033390301329DELTALIMACORPORATE SPAMBL2025-06-10
08033390301336DELTALIMACORPORATE SPAMBL2025-06-10
00822409016174Tri-plusOrtho Development CorporationMBL2023-11-22