KinematX

GUDID 00842078112014

Radial Body Assembly - LEFT, +0

EXTREMITY MEDICAL, LLC

Total wrist prosthesis
Primary Device ID00842078112014
NIH Device Record Key8ea12f72-7701-4e3a-9b81-e8b6859e8e5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinematX
Version Model Number137-30001-S
Company DUNS832720358
Company NameEXTREMITY MEDICAL, LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842078112014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-04
Device Publish Date2020-10-27

On-Brand Devices [KinematX]

00842078120019Radial Body Assembly - RIGHT, +6
00842078120002Radial Body Assembly - LEFT, +6
00842078119990Radial Body Assembly - RIGHT, +4
00842078119983Radial Body Assembly - LEFT, +4
008420781170334.75 mm Locking Screw x 50
008420781170024.75 mm Locking Screw x 45
008420781169994.75 mm Locking Screw x 40
008420781169684.75 mm Locking Screw x 35
008420781169374.75 mm Locking Screw x 30
008420781169064.75 mm Locking Screw x 25
008420781168764.75 mm Locking Screw x 20
008420781168524.75 mm Locking Screw x 15
00842078116838Standard Baseplate, 15mm Stem
00842078116814Standard Baseplate, 12mm Stem
00842078112090Carpal Cap; Sterile Packed
00842078112045Radial Body Assembly - RIGHT, +2
00842078112038Radial Body Assembly - LEFT, +2
00842078112021Radial Body Assembly - RIGHT, +0
00842078112014Radial Body Assembly - LEFT, +0
00842078111536KinematX Radial Stem - Size 3; Sterile Packed
00842078111529KinematX Radial Stem - Size 2; Sterile Packed
00842078111512KinematX Radial Stem - Size 1; Sterile Packed
00842078114612KinematX Total Instrument Tray

Trademark Results [KinematX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KINEMATX
KINEMATX
77834270 4321332 Live/Registered
Extremity Medical LLC
2009-09-24

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