FDA.reportPublic FDA data

EXETER

Primary DI
04546540153890
Brand
EXETER
Company
Howmedica Osteonics Corp.
Model
0586-0-326
Catalog number
0586-0-326
Device description
Femoral head
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
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540153890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540153890045465401538904546540153890

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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

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
10885862660824NovationExactech, Inc.LWJ2026-03-19
10885862661005N/AExactech, Inc.LWJ2026-03-19
10885862661067N/AExactech, Inc.LWJ2026-03-19
10885862661081N/AExactech, Inc.LWJ2026-03-19
10885862661098N/AExactech, Inc.LWJ2026-03-19
10885862658173EXACTECHExactech, Inc.LWJ2025-11-14
10885862658272EXACTECHExactech, Inc.LWJ2025-11-14
10885862658296EXACTECHExactech, Inc.LWJ2025-11-14
10885862658302EXACTECHExactech, Inc.LWJ2025-11-14
04719886904666U-Motion IIUNITED ORTHOPEDIC CORP.LWJ2025-09-15
04719886904673U-Motion IIUNITED ORTHOPEDIC CORP.LWJ2025-09-15
10885862653246NovationExactech, Inc.LWJ2025-05-15
00887868575563Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575600Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575624Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575655Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575723Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575822Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575907Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576027Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576133Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576164Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868577116Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868577888Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868578540Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868578557Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00889024655904Fitmore® Hip StemZimmer GmbHLWJ2023-02-23
07613327460254INSTRUMENTHowmedica Osteonics Corp.LWJ2022-12-20
10885862030948NAExactech, Inc.LWJ2022-10-04
10885862030962NAExactech, Inc.LWJ2022-10-04