Ulna Shortening Plating System CUTG-DIST-L

GUDID 00841506916132

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 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841506916132
• NIH Device Record Key: 4f04d0f8-91c0-4aab-9e35-ba41a6dc0da5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulna Shortening Plating System
• Version Model Number: Ulnar Shortening, Cutting Guide, Distal, Left
• Catalog Number: CUTG-DIST-L
• Company DUNS: 869056148
• Company Name: SKELETAL DYNAMICS L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506916132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201962

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-03
• Device Publish Date: 2020-11-25

On-Brand Devices [Ulna Shortening Plating System]

• 00841507516201: K-Wire, Diamond Tip, 1.6mm x 127mm
• 00841507516195: Drill, 3.5mm x 40mm
• 00841507416181: Cutting Blade, Proximal
• 00841507316177: Cutting Blade, Distal
• 00841507216163: Cottle Osteotome, 2.0mm
• 00841506916132: Ulnar Shortening, Cutting Guide, Distal, Left
• 00841506516097: Ulnar Shortening, Cutting Guide, Proximal, Left
• 00841506416083: Ulnar Shortening, Cutting Guide, Proximal, Right
• 00841506316666: Ulnar Shortening Plating System Sterilization Tray
• 00841506316079: Ulnar Shortening Plate, Distal, Short, Left
• 00841506216065: Ulnar Shortening Plate, Distal, Short, Right
• 00841506116051: Forceps, Bone Holding Medium, Compression
• 00841506116037: Oblique Compression Hole Guide
• 00841506115757: Thread-In Drill Guide, FreeFix, 3.5mm
• 00841506109985: PROTEAN Plate Bending Pliers, Large
• 00841506130705: Drill, 3.5mm x 40mm, Reusable
• 00841506117614: Drill Guide, FreeFixTM, Ulnar Shortening
• 00841506117577: Forceps, Bone Holding Medium, Compression , Right
• 00841506117560: Forceps, Bone Holding Medium, Compression , Left
• 00841506117089: Ulnar Shortening Plating System
• 00841506116662: Ulnar Shortening Plating System Sterilization Tray
• 00841506116204: K-Wire, Single Diamond, 1.6mm x 127mm
• 00841506116136: Ulnar Shortening, Cutting Guide, Distal, Left
• 00841506116129: Ulnar Shortening, Cutting Guide, Distal, Right
• 00841506116112: Ulnar Shortening, Cutting Guide, Oblique, Proximal
• 00841506116105: Ulnar Shortening, Cutting Guide, Oblique, Proximal
• 00841506116099: Ulnar Shortening, Cutting Guide, Proximal, Left
• 00841506116082: Ulnar Shortening, Cutting Guide, Proximal, Right
• 00841506116075: Ulnar Shortening Plate, Distal, Short, Left
• 00841506116068: Ulnar Shortening Plate, Distal, Short, Right
• 00841506109114: Driver, Peg, Reuseable
• 00841506108834: Driver, Peg, Torque Limiting, Reusable
• 00841506114446: Ulnar Shortening Plate, Proximal, Long
• 00841506114439: Ulnar Shortening Plate, Proximal, Short
• 00841506108841: Drill, Solid Side Cutting, 2.0mm x 40mm (OUS)
• 00841506117690: Instrument, Hohmann Retractor, Double Ended