Plate Positioning Guide

Primary DI
00887868539701
Brand
Plate Positioning Guide
Company
Biomet Orthopedics, LLC
Model
IFI-491457
Catalog number
IFI-491457
Published
2022-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110201000EXPLOR RADIAL HEAD PLATING SYSTEMBiomet, Inc.2011-07-21HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868539701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868539701008878685397018878685397010887868539701

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836224Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836248Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836255Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836262Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835999Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836002Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836019Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836026Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836033Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836040Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836057Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836064Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836071Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
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00885556836095Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836118Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836125Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836132Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836149Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836156Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556838785Total Foot System 2Smith & Nephew, Inc.HRS2022-12-21
00885556838785Total Foot System 2Smith & Nephew, Inc.HWC2022-12-21
00888867007475Arthrex®ARTHREX, INC.HRS2017-02-15
00888867007499Arthrex®ARTHREX, INC.HRS2017-02-15