IMPlate IMP-MCN-S46

GUDID 00841506102177

SKELETAL DYNAMICS L.L.C.

Arthrodesis nail, non-sterile
Primary Device ID00841506102177
NIH Device Record Keyca62079f-7f19-40c9-bb3f-50156696fb42
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPlate
Version Model NumberIMPLATE Nail, Metacarpal, Standard, 4.6mm
Catalog NumberIMP-MCN-S46
Company DUNS869056148
Company NameSKELETAL DYNAMICS L.L.C.
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com

Device Dimensions

Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506102177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-30

On-Brand Devices [IMPlate]

00841506104645IMPLATE Connector, 12mm x 10°
00841506104638IMPLATE Connector, 12mm x 5°
00841506104621IMPLATE Connector, 7mm x 10°
00841506104614IMPLATE Connector, 7mm x 5°
00841506104607IMPLATE Connector, 2mm x 10°
00841506104591IMPLATE Connector, 2mm x 5°
00841506103709Unicortical Screw, 2.8mm x 14.0mm, Ti
00841506103693Unicortical Screw, 2.8mm x 12.0mm, Ti
00841506103686Unicortical Screw, 2.8mm x 10.0mm, Ti
00841506103679Unicortical Screw, 2.8mm x 8.0mm, Ti
00841506103662Unicortical Screw, 2.8mm x 7.0mm, Ti
00841506103655Unicortical Screw, 2.8mm x 6.0mm, Ti
00841506103648Unicortical Screw, 2.8mm x 5.0mm, Ti
00841506103631Unicortical Screw, 2.8mm x 4.0mm, Ti
00841506103105Set Screw, 3.0mm x 2.0mm, CoCr
00841506102443IMPLATE Connector, 12mm x 22.5°
00841506102436IMPLATE Connector, 12mm x 15°
00841506102429IMPLATE Connector, 12mm x 7.5°
00841506102412IMPLATE Connector, 12mm x 0°
00841506102405IMPLATE Connector, 7mm x 22.5°
00841506102399IMPLATE Connector, 7mm x 15°
00841506102382IMPLATE Connector, 7mm x 7.5°
00841506102375IMPLATE Connector, 7mm x 0°
00841506102368IMPLATE Connector, 2mm x 22.5°
00841506102351IMPLATE Connector, 2mm x 15°
00841506102344IMPLATE Connector, 2mm x 7.5°
00841506102337IMPLATE Connector, 2mm x 0°
00841506102320IMPLATE Wrist Arthrodesis Nail System
00841506102313IMPLATE Spreader, Wrist Arthrodesis Nails
00841506102306IMPLATE Rasp 2, Distal Radius, 7.0mm x 70mm
00841506102290IMPLATE Rasp 1, Distal Radius, 5.5mm x 70mm
00841506102283IMPLATE Reamer 5, Metacarpal, 5.0mm x 87mm
00841506102276IMPLATE Reamer 4, Metacarpal, 4.5mm x 87mm
00841506102269IMPLATE Reamer 3, Metacarpal, 4.0mm x 87mm
00841506102252IMPLATE Reamer 2, Metacarpal, 3.4mm x 87mm
00841506102245IMPLATE Reamer 1, Metacarpal, 2.7mm x 87mm
00841506102238IMPLATE, Minimum Gap Gauge
00841506102221IMPLATE Awl, Wrist Arthrodesis Nails
00841506102214IMPLATE Lock Screw, Unicort. Drill Guide
00841506102207IMPLATE Uni Drill Guide, Drill Sleeve
00841506102191IMPLATE Uni Drill Guide, DRMC Nails
00841506102184IMPLATE Uni Drill Guide, Depth Gauge
00841506102177IMPLATE Nail, Metacarpal, Standard, 4.6mm
00841506102160IMPLATE Nail, Metacarpal, Standard, 4.0mm
00841506102153IMPLATE Nail, Metacarpal, Mini
00841506102146IMPLATE Rasp, Flaring and Troughing
00841506102139IMPLATE Drill, Unicortical 3mm x 41mm
00841506102122IMPLATE Nail, Distal Radius, Short, Ti
00841506102115IMPLATE Nail, Distal Radius, Long, Ti
00841506102061Handle, Mini Quick Connect, Fixed

Trademark Results [IMPlate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPLATE
IMPLATE
85031895 3967758 Live/Registered
SKELETAL DYNAMICS, INC.
2010-05-06
IMPLATE
IMPLATE
78732014 not registered Dead/Abandoned
Amgen Inc.
2005-10-12
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