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
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

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