FDA.reportPublic FDA data

HEALEY HIP SYSTEM

Primary DI
00880304201194
Brand
HEALEY HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
11-105454
Catalog number
11-105454
Published
2020-03-25
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
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921139000HEALEY REVISION COMPONENT SYSTEMBiomet, Inc.1992-07-01JDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304201194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304201194008803042011948803042011940880304201194

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

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
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286800570Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800587Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800594Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800600Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800617Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800624Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800631Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800648Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00880304498167Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304498174Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499065Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499072Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304452732TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452749TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452756TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
B27826000025E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
B27826000026E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
00880304461604Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461611Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461628Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461635Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461642Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461659Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461666Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461673Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461680Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461697Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461703Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461765Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461772Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24