IJS TPDG-SSD-20

GUDID 00841506105314

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00841506105314
NIH Device Record Key9ed59efb-8219-4442-a160-8382fff96e14
Commercial Distribution StatusIn Commercial Distribution
Brand NameIJS
Version Model NumberTissue Protector / Drill Guide, Single Sided, 2.0m
Catalog NumberTPDG-SSD-20
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506105314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZIInternal hinged elbow fixator

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 Date2017-10-30

On-Brand Devices [IJS]

00841506105314Tissue Protector / Drill Guide, Single Sided, 2.0m
00841506105307Dorsal Spanning Plate, Short, Ti
00841506105291IJS Sterilization Tray, Instrument Tray (Branch)
00841506105284IJS Sterilization Tray, Caddy (Branch)
00841506105277IJS Sterilization Tray, Lid (Branch)
00841506105260IJS Sterilization Tray, Base (Branch)
00841506105253IJS-E Sterilization Tray
00841506105246IJS-ELBOW, Counter Torque Tool
00841506105239IJS-E Axis Centering Guide
00841506105222Drill, Solid Side Cutting, 2.5mm x 80mm
00841506105215Depth Gauge, Med. Standard, 50mm
00841506105208IJS-E Drill, Cann Distal Cutting, 2.7mm x 70mm
00841506105192IJS-E Depth Gauge, Over K-Wire
00841506105185IJS-E Axis Guide, Lateral Approach, Sm
00841506105178IJS-E Axis Guide, Lateral Approach, Md
00841506105161IJS-E Axis Guide, Lateral Approach, Lg
00841506105154IJS-E K-Wire Guide, 1.5mm
00841506105147IJS-E Axis Pin 2.5mm x 70mm
00841506105130IJS-E Axis Pin 2.5mm x 65mm
00841506105123IJS-E Axis Pin 2.5mm x 60mm
00841506105116IJS-E Axis Pin 2.5mm x 55mm
00841506105109IJS-E Axis Pin 2.5mm x 50mm
00841506105093IJS-E Axis Pin 2.5mm x 45mm
00841506105086IJS-E Axis Pin 2.5mm x 40mm
00841506105079IJS-E Axis Pin 2.5mm x 35mm
00841506105062IJS-E Axis Pin 2.5mm x 30mm
00841506105055Screw, Polyaxial Non Locking, 3.5mm x 44mm, Ti
00841506105048Screw, Polyaxial Non Locking, 3.5mm x 42mm, Ti
00841506105031Screw, Polyaxial Non Locking, 3.5mm x 40mm, Ti
00841506105024Screw, Polyaxial Non Locking, 3.5mm x 38mm, Ti
00841506105017Screw, Polyaxial Non Locking, 3.5mm x 36mm, Ti
00841506105000Screw, Polyaxial Non Locking, 3.5mm x 34mm, Ti
00841506104997Screw, Polyaxial Non Locking, 3.5mm x 32mm, Ti
00841506104980Screw, Polyaxial Non Locking, 3.5mm x 30mm, Ti
00841506104973Screw, Polyaxial Non Locking, 3.5mm x 28mm, Ti
00841506104966Screw, Polyaxial Non Locking, 3.5mm x 26mm, Ti
00841506104959Screw, Polyaxial Non Locking, 3.5mm x 24mm, Ti
00841506104942Screw, Polyaxial Non Locking, 3.5mm x 22mm, Ti
00841506104935Screw, Polyaxial Non Locking, 3.5mm x 20mm, Ti
00841506104928Screw, Polyaxial Non Locking, 3.5mm x 18mm, Ti
00841506104911Screw, Polyaxial Non Locking, 3.5mm x 16mm, Ti
00841506104904IJS-E Base Plate Assembly
00841506104898Packaged IJS-E System
00841506132945IJS Axis Trajectory Guide, Rotated, Large, Left
00841506132938IJS Axis Trajectory Guide, Rotated, Large, Right
00841506132921IJS Axis Trajectory Guide, Rotated, Medium, Left
00841506132914IJS Axis Trajectory Guide, Rotated, Medium, Right
00841506132907IJS Axis Trajectory Guide, Rotated, Small, Left
00841506132891IJS Axis Trajectory Guide, Rotated, Small, Right
00841506132877Cutting Pliers
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