FDA.reportPublic FDA data

STRIDE Unicondylar Knee

Primary DI
00841153100007
Brand
STRIDE Unicondylar Knee
Company
BLUE BELT TECHNOLOGIES, INC.
Model
110023
Device description
STRIDE Tibial Tray Implant SIZE 1 RM/LL
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841153100007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841153100007008411531000078411531000070841153100007

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated unicondylar knee tibia prosthesis, metallicA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component and an insert, and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-452-4910customersupport@bluebelttech.com

Regulatory Flags#

DUNS number
015299627
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841153100014STRIDE Unicondylar Knee1100242015-09-24
00841153100021STRIDE Unicondylar Knee1100252015-09-24
00841153100038STRIDE Unicondylar Knee 1100262015-09-24
00841153100045STRIDE Unicondylar Knee1100272015-09-24
00841153100052STRIDE Unicondylar Knee1100282015-09-24
00841153100069STRIDE Unicondylar Knee1100292015-09-24
00841153100076STRIDE Unicondylar Knee1100302015-09-24
00841153100083STRIDE Unicondylar Knee1100312015-09-24
00841153100090STRIDE Unicondylar Knee1100322015-09-24
00841153100106STRIDE Unicondylar Knee1100332015-09-24
00841153100113STRIDE Unicondylar Knee1100342015-09-24
00841153100120STRIDE Unicondylar Knee1100352015-09-24
00841153100137STRIDE Unicondylar Kne1100362015-09-24
00841153100144STRIDE Unicondylar Knee1100372015-09-24
00841153100151STRIDE Unicondylar Knee1100382015-09-24
00841153100168STRIDE Unicondylar Knee1100392015-09-24
00841153100175STRIDE Unicondylar Knee1100402015-09-24
00841153100182STRIDE Unicondylar Knee1100412015-09-24
00841153100199STRIDE Unicondylar Knee1100422015-09-24
00841153100205STRIDE Unicondylar Knee1100432015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327127423INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24