Ulna Shortening Plating System CUTG-PRX-L

GUDID 00841506116099

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00841506116099
NIH Device Record Keyd8608458-ab14-41a2-b383-7f3b716e1fd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlna Shortening Plating System
Version Model NumberUlnar Shortening, Cutting Guide, Proximal, Left
Catalog NumberCUTG-PRX-L
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 Usefalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100841506116099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


[00841506116099]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

On-Brand Devices [Ulna Shortening Plating System]

00841507516201K-Wire, Diamond Tip, 1.6mm x 127mm
00841507516195Drill, 3.5mm x 40mm
00841507416181Cutting Blade, Proximal
00841507316177Cutting Blade, Distal
00841507216163Cottle Osteotome, 2.0mm
00841506916132Ulnar Shortening, Cutting Guide, Distal, Left
00841506516097Ulnar Shortening, Cutting Guide, Proximal, Left
00841506416083Ulnar Shortening, Cutting Guide, Proximal, Right
00841506316666Ulnar Shortening Plating System Sterilization Tray
00841506316079Ulnar Shortening Plate, Distal, Short, Left
00841506216065Ulnar Shortening Plate, Distal, Short, Right
00841506116051Forceps, Bone Holding Medium, Compression
00841506116037Oblique Compression Hole Guide
00841506115757Thread-In Drill Guide, FreeFix, 3.5mm
00841506109985PROTEAN Plate Bending Pliers, Large
00841506130705Drill, 3.5mm x 40mm, Reusable
00841506117614Drill Guide, FreeFixTM, Ulnar Shortening
00841506117577Forceps, Bone Holding Medium, Compression , Right
00841506117560Forceps, Bone Holding Medium, Compression , Left
00841506117089Ulnar Shortening Plating System
00841506116662Ulnar Shortening Plating System Sterilization Tray
00841506116204K-Wire, Single Diamond, 1.6mm x 127mm
00841506116136Ulnar Shortening, Cutting Guide, Distal, Left
00841506116129Ulnar Shortening, Cutting Guide, Distal, Right
00841506116112Ulnar Shortening, Cutting Guide, Oblique, Proximal
00841506116105Ulnar Shortening, Cutting Guide, Oblique, Proximal
00841506116099Ulnar Shortening, Cutting Guide, Proximal, Left
00841506116082Ulnar Shortening, Cutting Guide, Proximal, Right
00841506116075Ulnar Shortening Plate, Distal, Short, Left
00841506116068Ulnar Shortening Plate, Distal, Short, Right
00841506109114Driver, Peg, Reuseable
00841506108834Driver, Peg, Torque Limiting, Reusable
00841506114446Ulnar Shortening Plate, Proximal, Long
00841506114439Ulnar Shortening Plate, Proximal, Short
00841506108841Drill, Solid Side Cutting, 2.0mm x 40mm (OUS)
00841506117690Instrument, Hohmann Retractor, Double Ended

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