Proximal Humerus Plating System PHP-INSRT-ABOT

GUDID 00841506140957

Proximal Humerus Fixation System, Tray A, Bottom Insert

SKELETAL DYNAMICS L.L.C.

Device sterilization/disinfection container, reusable
Primary Device ID00841506140957
NIH Device Record Key5f24d985-0e19-4dfd-8c14-81f2806dfbe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameProximal Humerus Plating System
Version Model NumberProximal Humerus Fixation System, Tray A, Bottom I
Catalog NumberPHP-INSRT-ABOT
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 Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506140957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

[00841506140957]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-09
Device Publish Date2025-12-01

On-Brand Devices [Proximal Humerus Plating System]

00841506146393K-Wire, Single Diamond Tip, Threaded with Stop, 2.0mm x 152mm
00841506146386Bending Rod, MT
00841506146287Screw, Variable Angle Locking, 3.0mm x 50mm, CoCr
00841506146270Screw, Variable Angle Locking, 3.0mm x 48mm, CoCr
00841506146263Screw, Variable Angle Locking, 3.0mm x 46mm, CoCr
00841506146249Screw, Variable Angle Locking, 3.0mm x 44mm, CoCr
00841506146232Screw, Variable Angle Locking, 3.0mm x 42mm, CoCr
00841506146225Screw, Variable Angle Locking, 3.0mm x 40mm, CoCr
00841506146218Screw, Variable Angle Locking, 3.0mm x 38mm, CoCr
00841506146201Screw, Variable Angle Locking, 3.0mm x 36mm, CoCr
00841506146195Screw, Variable Angle Locking, 3.0mm x 34mm, CoCr
00841506146188Screw, Variable Angle Locking, 3.0mm x 32mm, CoCr
00841506146171Screw, Variable Angle Locking, 3.0mm x 30mm, CoCr
00841506146164Screw, Variable Angle Locking, 3.0mm x 28mm, CoCr
00841506146157Screw, Variable Angle Locking, 3.0mm x 26mm, CoCr
00841506146140Screw, Variable Angle Locking, 3.0mm x 24mm, CoCr
00841506146133Screw, Variable Angle Locking, 3.0mm x 22mm CoCr
00841506146126Screw, Variable Angle Locking, 3.0mm x 20mm CoCr
00841506145976FreeFix, Proximal Humerus Plate, 3 Slot, Left, Ti
00841506145969FreeFix, Proximal Humerus Plate, 3 Slot, Right, Ti
00841506145945Depth Gauge, PHP
00841506145914Proximal Humerus, AP Buttress Plate, Left, Ti
00841506145907Proximal Humerus, AP Buttress Plate, Right, Ti
00841506145891FreeFix, Proximal Humerus Plate, Curved, 4 Slot, Left, Ti
00841506145884FreeFix, Proximal Humerus Plate, Curved, 4 Slot, Right, Ti
00841506141190Proximal Humerus Fixation System, Tray B, AIMing Guide Caddy
00841506141008Proximal Humerus Fixation System, Tray B, Bottom Insert
00841506140995Proximal Humerus Fixation System, Tray B, Top Insert
00841506140988Proximal Humerus Fixation System, Tray B, Lid
00841506140971Proximal Humerus Fixation System, Tray B, Base
00841506140964Proximal Humerus Fixation System, Tray B
00841506140957Proximal Humerus Fixation System, Tray A, Bottom Insert
00841506140940Proximal Humerus Fixation System, Tray A, Implant Caddy
00841506140933Proximal Humerus Fixation System, Tray A, Diaphyseal Screw Caddy
00841506140926Proximal Humerus Fixation System, Tray A, Metaphyseal Screw Caddy
00841506140919Proximal Humerus Fixation System, Tray A, Top Insert
00841506140902Proximal Humerus Fixation System, Tray A, Lid
00841506140896Proximal Humerus Fixation System, Tray A, Base
00841506140889Proximal Humerus Fixation System, Tray A
00841506140001Drill Guide, FreeFix, PHP
00841506139999Thread-In Pin Guide, FreeFix, 2.4mm
00841506139982Screw, Variable Angle Locking, 3.5mm x 70mm, CoCr
00841506139975Screw, Variable Angle Locking, 3.5mm x 65mm, CoCr
00841506139968Screw, Variable Angle Locking, 3.5mm x 60mm, CoCr
00841506139951Screw, Variable Angle Locking, 3.5mm x 58mm, CoCr
00841506139944Screw, Variable Angle Locking, 3.5mm x 56mm, CoCr
00841506139937Screw, Variable Angle Locking, 3.5mm x 54mm, CoCr
00841506139920Screw, Variable Angle Locking, 3.5mm x 52mm, CoCr
00841506139913Screw, Variable Angle Locking, 3.5mm x 50mm, CoCr
00841506139906Screw, Variable Angle Locking, 3.5mm x 48mm, CoCr
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