FDA.reportPublic FDA data

STRIDE

Primary DI
00885556628065
Brand
STRIDE
Company
Smith & Nephew, Inc.
Model
PFSR100890
Catalog number
PFSR100890
Device description
Stride Femoral Finishing Block Size 1 LM/RL
Published
2016-01-31
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
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
00885556628065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556628065008855566280658855566280650885556628065

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)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

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