FDA.reportPublic FDA data

THP™ Hip Fracture Plating System

Primary DI
00887868164293
Brand
THP™ Hip Fracture Plating System
Company
Biomet Orthopedics, LLC
Model
14-451004
Catalog number
14-451004
Published
2017-12-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140018000
K173826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140018000TSP HIP FRACTURE PLATING SYSTEMBiomet, Inc.2014-04-04JDO
K173826000THP Hip Fracture Plating SystemBiomet, Inc.2018-02-07JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868164293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868164293008878681642938878681642930887868164293

GMDN Terms#

Term, Definition table
TermDefinition
Hip internal fixation systemAn assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
10886982174994DHSSynthes GmbHJDO2015-09-14
10886982175007DHSSynthes GmbHJDO2015-09-14
10886982175014DHSSynthes GmbHJDO2015-09-14
10886982175021DHSSynthes GmbHJDO2015-09-14
10886982175038DHSSynthes GmbHJDO2015-09-14
10886982175045DHSSynthes GmbHJDO2015-09-14
10886982175052DHSSynthes GmbHJDO2015-09-14
10886982175069DHSSynthes GmbHJDO2015-09-14
10886982175076DHSSynthes GmbHJDO2015-09-14
10886982175083DHSSynthes GmbHJDO2015-09-14
10886982175090DHSSynthes GmbHJDO2015-09-14
10886982175106DHSSynthes GmbHJDO2015-09-14
10886982175113DHSSynthes GmbHJDO2015-09-14
10886982175120DHSSynthes GmbHJDO2015-09-14
10886982175137DHSSynthes GmbHJDO2015-09-14
10886982175144DHSSynthes GmbHJDO2015-09-14
10886982175151DHSSynthes GmbHJDO2015-09-14
10886982175168DHSSynthes GmbHJDO2015-09-14
10886982175175DHSSynthes GmbHJDO2015-09-14
10886982175182DHSSynthes GmbHJDO2015-09-14
10886982175212DHSSynthes GmbHJDO2015-09-14
10886982175229DHSSynthes GmbHJDO2015-09-14
10886982175236DHSSynthes GmbHJDO2015-09-14
10886982175243DHSSynthes GmbHJDO2015-09-14
10886982175250DHSSynthes GmbHJDO2015-09-14
10886982175267DHSSynthes GmbHJDO2015-09-14
10886982175274DHSSynthes GmbHJDO2015-09-14
10886982175281DHSSynthes GmbHJDO2015-09-14
10886982175298DHSSynthes GmbHJDO2015-09-14
10886982175304DHSSynthes GmbHJDO2015-09-14