Distal Elbow Plating System PUPF-8SPR

GUDID 00841506141480

FreeFix, Proximal Ulna Plate, 8 Slot Plus, Right

SKELETAL DYNAMICS L.L.C.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00841506141480
NIH Device Record Key1a6cc358-0e71-4541-87f6-659eaed45852
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Elbow Plating System
Version Model NumberFreeFix, Proximal Ulna Plate, 8 Slot Plus, Right
Catalog NumberPUPF-8SPR
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506141480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

[00841506141480]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-13
Device Publish Date2026-03-05

On-Brand Devices [Distal Elbow Plating System]

00841506109442Screw, Polyaxial Non Locking, 3.5mm x 14mm, Ti - O
00841506109435Screw, Polyaxial Non Locking, 3.5mm x 12mm, Ti - O
00841506109428Screw, Polyaxial Non Locking, 3.5mm x 10mm, Ti - O
00841506109411Screw, Polyaxial Non Locking, 3.5mm x 8mm, Ti - OB
00841506109299Distal Elbow System, Tray B - OBSOLETE
00841506109282Distal Elbow System, Tray A - OBSOLETE
00841506109183Bending Irons, PUP
00841506107318K-Wire, Standard Tip, 1.5mm x 127mm
00841506107264Large Reduction Forceps
00841506107257Distal Elbow Set Tray B
00841506107240Distal Elbow Set Tray A
00841506107202Screw, Multi-Thread Compression, 3.5mm x 65mm, Ti
00841506107196Screw, Multi-Thread Locking, 3.5mm x 65mm, Ti
00841506107189Screw, Polyaxial Locking, 3.0mm x 40mm Cannulated,
00841506107172Screw, Polyaxial Locking, 3.0mm x 38mm Cannulated,
00841506107165Screw, Polyaxial Locking, 3.0mm x 36mm Cannulated,
00841506107158Screw, Polyaxial Locking, 3.0mm x 34mm Cannulated,
00841506107141Screw, Polyaxial Locking, 3.0mm x 32mm Cannulated,
00841506107134Screw, Polyaxial Locking, 3.0mm x 30mm Cannulated,
00841506107127Screw, Polyaxial Locking, 3.0mm x 28mm Cannulated,
00841506107110Screw, Polyaxial Locking, 3.0mm x 26mm Cannulated,
00841506107103Screw, Polyaxial Locking, 3.0mm x 24mm Cannulated,
00841506107097Screw, Polyaxial Locking, 3.0mm x 22mm Cannulated,
00841506107080Screw, Multi-Thread Compression, 3.5mm x 70mm, Ti
00841506107073Screw, Multi-Thread Compression, 3.5mm x 60mm, Ti
00841506107066Screw, Multi-Thread Compression, 3.5mm x 55mm, Ti
00841506107059Screw, Multi-Thread Compression, 3.5mm x 50mm, Ti
00841506107042Screw, Multi-Thread Compression, 3.5mm x 45mm, Ti
00841506107035Screw, Multi-Thread Compression, 3.5mm x 40mm, Ti
00841506107028Screw, Multi-Thread Compression, 3.5mm x 38mm, Ti
00841506107011Screw, Multi-Thread Compression, 3.5mm x 36mm, Ti
00841506107004Screw, Multi-Thread Compression, 3.5mm x 34mm, Ti
00841506106991Screw, Multi-Thread Compression, 3.5mm x 32mm, Ti
00841506106984Screw, Multi-Thread Compression, 3.5mm x 30mm, Ti
00841506106977Screw, Multi-Thread Compression, 3.5mm x 28mm, Ti
00841506106960Screw, Multi-Thread Compression, 3.5mm x 26mm, Ti
00841506106953Screw, Multi-Thread Compression, 3.5mm x 24mm, Ti
00841506106946Screw, Multi-Thread Compression, 3.5mm x 22mm, Ti
00841506106939Screw, Multi-Thread Compression, 3.5mm x 20mm, Ti
00841506106922Screw, Multi-Thread Compression, 3.5mm x 18mm, Ti
00841506106915Screw, Multi-Thread Compression, 3.5mm x 16mm, Ti
00841506106908Screw, Multi-Thread Compression, 3.5mm x 14mm, Ti
00841506106892Screw, Multi-Thread Compression, 3.5mm x 12mm, Ti
00841506106885Screw, Multi-Thread Compression, 3.5mm x 10mm, Ti
00841506106878Screw, Multi-Thread Locking, 3.5mm x 70mm, Ti
00841506106861Screw, Multi-Thread Locking, 3.5mm x 60mm, Ti
00841506106854Screw, Multi-Thread Locking, 3.5mm x 55mm, Ti
00841506106847Screw, Multi-Thread Locking, 3.5mm x 50mm, Ti
00841506106830Screw, Multi-Thread Locking, 3.5mm x 45mm, Ti
00841506106823Screw, Multi-Thread Locking, 3.5mm x 40mm, Ti
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