FDA.reportPublic FDA data

T TAP HIP SYSTEM

Primary DI
00880304223523
Brand
T TAP HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
12-165166
Catalog number
12-165166
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
KMCProsthesis, hip, semi-constrained, composite/metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMCProsthesis, Hip, Semi-Constrained, Composite/MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853259000MALLORY/HEAD TOTAL HIP SYSTEMBiomet, Inc.1985-11-01KMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304223523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304223523008803042235238803042235230880304223523

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

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
00887868308222Biomet® Hip SystemBiomet Orthopedics, LLCKMC2019-04-18
00887868308239Biomet® Hip SystemBiomet Orthopedics, LLCKMC2019-04-18
00887868308246Biomet® Hip SystemBiomet Orthopedics, LLCKMC2019-04-18
00887868264788Biomet® Hip SystemBiomet Orthopedics, LLCKMC2019-02-15
00887868264795Biomet® Hip SystemBiomet Orthopedics, LLCKMC2019-02-15
00887868264801Biomet® Hip SystemBiomet Orthopedics, LLCKMC2019-02-15
00880304045958MODULAR HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304223530T TAP HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304223547T TAP HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304223554T TAP HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304256446BIOMET HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304256460BIOMET HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304256484BIOMET HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24