KASM

GUDID 00822409007554

Small 37A/P x 60M/L Femoral Spacer Mold

Ortho Development Corporation

Orthopaedic cement spacer mould
Primary Device ID00822409007554
NIH Device Record Keyab3f24bb-673a-4a40-8093-db6b5e5e1551
Commercial Distribution StatusIn Commercial Distribution
Brand NameKASM
Version Model Number669-1060
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Width60 Millimeter
Width60 Millimeter
Width60 Millimeter
Width60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409007554 [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 Number4
Public Version Date2019-09-23
Device Publish Date2015-08-31

On-Brand Devices [KASM]

00822409007608Large 52A/P x 81M/L Tibial Spacer Mold
00822409007592Medium 45A/P x 70M/L Tibial Spacer Mold
00822409007585Small 39A/P x 58M/L Tibial Spacer Mold
00822409007578Large 53A/P x 75M/L Femoral Spacer Mold
00822409007561Medium 44A/P x 67M/L Femoral Spacer Mold
00822409007554Small 37A/P x 60M/L Femoral Spacer Mold

Trademark Results [KASM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KASM
KASM
85052135 3992272 Live/Registered
Ortho Development Corporation
2010-06-01

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