FDA.reportPublic FDA data

Allure Hip Stem

Primary DI
04026575448296
Brand
Allure Hip Stem
Company
WALDEMAR LINK GmbH & Co. KG
Model
297-101/05
Device description
Allure Broach
Published
2025-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTQBroach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575448296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575448296040265754482964026575448296

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575448678MobileLink Acetabular Cup System183-353/40183-353/402026-07-09
04026575448685MobileLink Acetabular Cup System183-363/40183-363/402026-07-09
04026575448760MobileLink Acetabular Cup System183-354/40183-354/402026-07-09
04026575448777MobileLink Acetabular Cup System183-355/40183-355/402026-07-09
04026575448784MobileLink Acetabular Cup System183-356/40183-356/402026-07-09
04026575448791MobileLink Acetabular Cup System183-364/40183-364/402026-07-09
04026575448807MobileLink Acetabular Cup System183-365/40183-365/402026-07-09
04026575448814MobileLink Acetabular Cup System183-366/40183-366/402026-07-09
04026575448821MobileLink Acetabular Cup System183-373/40183-373/402026-07-09
04026575448838MobileLink Acetabular Cup System183-374/40183-374/402026-07-09
04026575448845MobileLink Acetabular Cup System183-375/40183-375/402026-07-09
04026575448852MobileLink Acetabular Cup System183-376/40183-376/402026-07-09
04026575448869MobileLink Acetabular Cup System183-743/40183-743/402026-07-09
04026575448876MobileLink Acetabular Cup System183-744/40183-744/402026-07-09
04026575448883MobileLink Acetabular Cup System183-745/40183-745/402026-07-09
04026575448890MobileLink Acetabular Cup System183-746/40183-746/402026-07-09
04026575348213SPII Model Lubinus128-950/35128-950/352015-11-01
04026575348220SPII Model Lubinus128-951/35128-951/352015-11-01
04026575348237SPII Model Lubinus128-952/35128-952/352015-11-01
04026575348244SPII Model Lubinus128-953/35128-953/352015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295079965AML EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080176EXCEL TRI-LOCKDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080183EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080190EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080206EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080213EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080220EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080237EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080244EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080251NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080268NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080275EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080282EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080299EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080305EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080312EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080329EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080336EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080343NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080350NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080367EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080374EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080381EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295082057TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082064TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082071TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082088TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082095TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082101TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082118TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24