FDA.reportPublic FDA data

Accolade

Primary DI
04546540669469
Brand
Accolade
Company
Howmedica Osteonics Corp.
Model
6721-0127
Catalog number
6721-0127
Device description
127 Degree Neck Angle Hip 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
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
04546540669469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540669469045465406694694546540669469

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) 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 coated with a material (e.g., porous materials, hydroxyapatite) 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 may be performed with or without 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
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