Humeral Fixation Set OADG-FF-T35

GUDID 00841506129556

SKELETAL DYNAMICS L.L.C.

Surgical drill guide, reusable
Primary Device ID00841506129556
NIH Device Record Key0ca93f56-b3d9-4149-8031-8c5ad7c0ea28
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumeral Fixation Set
Version Model NumberThread-in Off Axis Drill Guide, FreeFix™ 3.5mm
Catalog NumberOADG-FF-T35
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506129556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

[00841506129556]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-01
Device Publish Date2023-12-22

On-Brand Devices [Humeral Fixation Set]

00841506135205Tap, 4.5mm x 140mm
00841506135199Tap, 3.5mm x 140mm
00841506134888Humeral Fixation System B
00841506134871Humeral Fixation System A
00841506132525Humeral Fixation Set Tray B, Bottom Insert
00841506132518Humeral Fixation Set Tray B, Middle Insert
00841506132501Humeral Fixation Set Tray B, Top Insert
00841506132495Humeral Fixation Set Tray B, Lid
00841506132488Humeral Fixation Set Tray B, Base
00841506132464Humeral Fixation Set Tray A, PROTEAN Screw Caddy
00841506132457Humeral Fixation Set Tray A, Midshaft Humerus Scre
00841506132440Humeral Fixation Set Tray A, Distal Humerus Screw
00841506132433Humeral Fixation Set Tray A, Middle Insert
00841506132426Humeral Fixation Set Tray A, Top Insert
00841506132419Humeral Fixation Set Tray A, Lid
00841506132402Humeral Fixation Set Tray A, Base
00841506132396Humeral Fixation Set Tray A
00841506132389Distal Humerus Plate, Supracondylar, 8 Hole, Left
00841506132372Distal Humerus Plate, Supracondylar, 8 Hole, Right
00841506132365Distal Humerus Plate, Supracondylar, 6 Hole, Left
00841506132358Distal Humerus Plate, Supracondylar, 6 Hole, Right
00841506132341Drill Guide, FreeFix™, HPS
00841506131047K-Wire, Single Diamond Trocar, 1.5 mm x 229 mm
00841506130699Drill, 3.5mm x 50mm, Reusable
00841506130682Drill, 3.2mm x 50mm, Reusable
00841506130675Drill, 2.0mm x 80mm, Reusable
00841506130668Drill, Cannulated, 4.0mm x 20mm, Reusable
00841506130651Drill, Cannulated, 3.7mm x 80mm, Reusable
00841506130644Drill, 3.2mm / 4.5mm, Reusable
00841506130637Countersink, 6.5mm, Reusable
00841506130613Drill, Cannulated, PLS, 2.4mm x 40mm, Reusable
00841506130446Screw, FreeFix™ Compression, 3.5mm x 44mm, Ti
00841506130439Screw, FreeFix™ Compression, 3.5mm x 42mm, Ti
00841506130422Screw, FreeFix™ Compression, 3.5mm x 40mm, Ti
00841506130415Screw, FreeFix™ Compression, 3.5mm x 38mm, Ti
00841506130408Screw, FreeFix™ Compression, 3.5mm x 36mm, Ti
00841506130392Screw, FreeFix™ Compression, 3.5mm x 34mm, Ti
00841506130385Screw, FreeFix™ Compression, 3.5mm x 32mm, Ti
00841506130378Screw, FreeFix™ Compression, 3.5mm x 30mm, Ti
00841506130361Screw, FreeFix™ Compression, 3.5mm x 28mm, Ti
00841506130354Screw, FreeFix™ Compression, 3.5mm x 26mm, Ti
00841506130347Screw, FreeFix™ Compression, 3.5mm x 24mm, Ti
00841506130330Screw, FreeFix™ Compression, 3.5mm x 22mm, Ti
00841506130323Screw, FreeFix™ Compression, 3.5mm x 20mm, Ti
00841506130316Screw, FreeFix™ Compression, 3.5mm x 18mm, Ti
00841506130293Screw, FreeFix™ Compression, 3.5mm x 16mm, Ti
00841506130262Screw, FreeFix™ Compression, 3.5mm x 12mm, Ti
00841506130248Screw, FreeFix™ Compression, 3.5mm x 10mm, Ti
00841506130217Screw, FreeFix™ Locking, 3.5mm x 44mm, Ti
00841506130200Screw, FreeFix™ Locking, 3.5mm x 42mm, Ti
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