Symmetric Total Knee Tibial Tray 22-02-126

GUDID B04622021260

Size : 6 Symmetric Total Knee Tibial Tray

SIGNAL MEDICAL CORPORATION

Coated unicondylar knee tibia prosthesis Coated unicondylar knee tibia prosthesis
Primary Device IDB04622021260
NIH Device Record Keyaafc1a0a-ff1a-4a43-84ca-f857a2864481
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymmetric Total Knee Tibial Tray
Version Model NumberSize: 6
Catalog Number22-02-126
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

Phone1-810-364-7070
Emailjgorney@signalmd.com
Phone1-810-364-7070
Emailjgorney@signalmd.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB04622021260 [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 Date2015-12-16

On-Brand Devices [Symmetric Total Knee Tibial Tray]

B04622021270Symmetric Total Knee Tibial Tray Size 7
B04622021260Size : 6 Symmetric Total Knee Tibial Tray
B04622021250Symmetric Total Knee Tibial Tray Size 5
B04622021240Symmetric Total Knee Tibial Tray Size 4
B04622021230Symmetric Total Knee Tibial Tray Size: 3

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