FDA.reportPublic FDA data

T TAP HIP SYSTEM

Primary DI
00880304223547
Brand
T TAP HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
12-165174
Catalog number
12-165174
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
00880304223547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304223547008803042235478803042235470880304223547

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
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

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
00880304223523T TAP HIP SYSTEMBiomet Orthopedics, LLCKMC2015-10-24
00880304223530T 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