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
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
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