FDA.reportPublic FDA data

STRIDE Unicondylar Knee

Primary DI
00841153100366
Brand
STRIDE Unicondylar Knee
Company
BLUE BELT TECHNOLOGIES, INC.
Model
110059
Device description
STRIDE Tibial Insert Implant SIZE E, 8 mm
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
00841153100366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841153100366008411531003668411531003660841153100366

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

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
00841153100007STRIDE Unicondylar Knee1100232015-09-24
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

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Primary DI, Brand, Company table
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