FDA.reportPublic FDA data

Vanguard® Knee Instruments

Primary DI
00887868497209
Brand
Vanguard® Knee Instruments
Company
Biomet Orthopedics, LLC
Model
32-488518
Catalog number
32-488518
Published
2022-05-08
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
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868497209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868497209008878684972098878684972090887868497209

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840096408690Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408706Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408713Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408720Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408737Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408744Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408751Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408768Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408775Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408782Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408799Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408805Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408812Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408829Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408836Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408843Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408850Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408867Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408874Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408881Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408898Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408904Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408911Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408928Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408935Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408942Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408959Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408966Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408973Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408980Viant Medical, LLCVIANT MEDICALHTO2020-09-03