FDA.reportPublic FDA data

BIO-MOORE HIP SYSTEM

Primary DI
00880304227972
Brand
BIO-MOORE HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
139010
Catalog number
139010
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
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K845025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K845025000AUSTIN-MOORE MODULAR HIP PROSTHESISBiomet, Inc.1985-04-19KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304227972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304227972008803042279728803042279720880304227972

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

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
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
07613153071273RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071631RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWL2015-09-24