FDA.reportPublic FDA data

HEALEY HIP SYSTEM

Primary DI
00880304201255
Brand
HEALEY HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
11-105462
Catalog number
11-105462
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
00880304201255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304201255008803042012558803042012550880304201255

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
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

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