FDA.reportPublic FDA data

EXETER

Primary DI
04546540153326
Brand
EXETER
Company
Howmedica Osteonics Corp.
Model
0580-1-443
Catalog number
0580-1-443
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
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540153326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540153326045465401533264546540153326

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
00887868475757Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868477171Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868477232Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868477256Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868478086Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868475375Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868475962Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868475979Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476044Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476068Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476310Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476860Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868477881Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476372Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476556Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476662Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476761Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868475399Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868475559Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868476990Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868477447Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
07613327511659INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
07613327511802INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
07613327511864INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
00887868475481Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868475511Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868475894Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868477669Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868477744Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868476235Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-03-12