Symmetric TK Femoral Component 22-01-02105

GUDID B0462201021050

5RT Symmetric TK Femoral Component

SIGNAL MEDICAL CORPORATION

Coated knee femur prosthesis
Primary Device IDB0462201021050
NIH Device Record Key61d47439-6b7d-4cec-b93c-66cc080c6287
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymmetric TK Femoral Component
Version Model Number5RT
Catalog Number22-01-02105
Company DUNS169289308
Company NameSIGNAL MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8103647070
Emailjgorney@signalmd.com
Phone8103647070
Emailjgorney@signalmd.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0462201021050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-05

On-Brand Devices [Symmetric TK Femoral Component]

B0462201021044RT Symmetric TK Femoral Component
B04622010210505RT Symmetric TK Femoral Component
B04622010200707LT Symmetric TK Femoral Component
B0462201020060Symmetric TK Femoral Component 6LT
B04622010200505LT Symmetric TK Femoral Component
B04622010200404LT Symmetric TK Femoral Component
B04622010210303RT Symmetric TK Femoral Component
B04622010200303LT Symmetric TK Femoral Component

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