FDA.reportPublic FDA data

EXPLOR

Primary DI
00880304210417
Brand
EXPLOR
Company
Biomet Orthopedics, LLC
Model
11-210035
Catalog number
11-210035
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
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040611000
K051385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040611000MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc.2004-06-04KWI
K051385000EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc.2005-08-05KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304210417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304210417008803042104178803042104170880304210417

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesisA sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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
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10886982300522NASynthes GmbHKWI2020-06-08
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10886982300577NASynthes GmbHKWI2020-06-08
10886982300584NASynthes GmbHKWI2020-06-08
10886982300591NASynthes GmbHKWI2020-06-08
10886982300607NASynthes GmbHKWI2020-06-08
10886982300614NASynthes GmbHKWI2020-06-08
10886982300621NASynthes GmbHKWI2020-06-08
10886982300638NASynthes GmbHKWI2020-06-08
10886982300645NASynthes GmbHKWI2020-06-08
10886982300652NASynthes GmbHKWI2020-06-08
10886982300669NASynthes GmbHKWI2020-06-08
10886982300676NASynthes GmbHKWI2020-06-08
10886982300683NASynthes GmbHKWI2020-06-08
10886982300690NASynthes GmbHKWI2020-06-08
10886982300706NASynthes GmbHKWI2020-06-08
10886982300737NASynthes GmbHKWI2020-06-08
10886982300744NASynthes GmbHKWI2020-06-08
10886982300751NASynthes GmbHKWI2020-06-08
10886982300768NASynthes GmbHKWI2020-06-08
10886982300775NASynthes GmbHKWI2020-06-08
10886982300782NASynthes GmbHKWI2020-06-08
10886982300799NASynthes GmbHKWI2020-06-08
10886982300805NASynthes GmbHKWI2020-06-08
10886982300812NASynthes GmbHKWI2020-06-08