Ulna Shortening Plating System USP-DLS

GUDID 00841506316079

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00841506316079
NIH Device Record Key59f41377-f70b-4970-b723-152b0cb7a73e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlna Shortening Plating System
Version Model NumberUlnar Shortening Plate, Distal, Short, Left
Catalog NumberUSP-DLS
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506316079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25

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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