DEVICE: LinkSymphoKnee (04026575262274)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
LinkSymphoKnee
880-605/15
In Commercial Distribution
880-605/15
WALDEMAR LINK GmbH & Co. KG
04026575262274
GS1

1
315675488 *Terms of Use
Modular Stem, Cylindrical Press-Fit
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64152 Knee tibia stem prosthesis
An implantable uncoated shaft-like device intended to be attached to the tibial baseplate of a modular knee tibia prosthesis to provide anchorage within the tibia. It has a threaded proximal end and is shaped to provide a tight fit with the internal tibial cortex; it is made of metallic materials.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KRO PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K202924 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
eb3d717e-4e09-4513-9682-44a9e07fb48d
October 15, 2021
1
October 07, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE