Symmetric Total Knee Tibial Tray 22-02-124

GUDID B04622021240

Symmetric Total Knee Tibial Tray Size 4

SIGNAL MEDICAL CORPORATION

Coated unicondylar knee tibia prosthesis Coated unicondylar knee tibia prosthesis
Primary Device IDB04622021240
NIH Device Record Key0703b34e-9337-48cd-b4ad-39b7bb62088b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymmetric Total Knee Tibial Tray
Version Model NumberSize: 4
Catalog Number22-02-124
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

Phone810-364-7070
Emailjgorney@signalmd.com
Phone810-364-7070
Emailjgorney@signalmd.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB04622021240 [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 Date2016-02-12

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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