FDA.reportPublic FDA data

MALLORY/HEAD INTERLOK HIP SYSTEM

Primary DI
00880304192058
Brand
MALLORY/HEAD INTERLOK HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
105606
Catalog number
105606
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911684000BIOMET COBALT-CHROME FEMORAL COMPONENTSBiomet, Inc.1991-06-27JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304192058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304192058008803041920588803041920580880304192058

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032071LineageMicroport Orthopedics Inc.JDI2026-08-18
00192629031937LineageMicroport Orthopedics Inc.JDI2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14