FDA.reportPublic FDA data

STRIDE

Primary DI
00885556626795
Brand
STRIDE
Company
Smith & Nephew, Inc.
Model
PFSI00001
Catalog number
PFSI00001
Device description
Stride Tibia Baseplate Size 1 RM/LL
Published
2016-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00885556626795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556626795008855566267958855566267950885556626795

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
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345711014MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711021MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711038MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711229MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711236MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711243MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711434MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711441MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711458MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711649MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711656MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711663MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711854MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711861MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711878MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712066MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712073MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712080MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712271MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712288MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712295MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712486MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712493MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712509MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752568MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752575MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752582MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752599MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752605MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752667MOTO Partial Knee SystemMedacta International SAHSX2025-08-05