Forearm Plating System MRP-142

GUDID 00841506114590

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: 00841506114590
• NIH Device Record Key: 11065075-3f4d-4709-af9e-e484a16e952e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forearm Plating System
• Version Model Number: FreeFix Midshaft Radius Plate, 142mm
• Catalog Number: MRP-142
• 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: true
• 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	00841506114590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200538

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 [Forearm Plating System]

• 00841506115887: FreeFix Depth Gage
• 00841506115740: FreeFix Midshaft Radius Plate, 188mm
• 00841506115399: FreeFix Midshaft Ulna Plate, 157mm
• 00841506115382: FreeFix Midshaft Ulna Plate, 127mm
• 00841506115375: FreeFix Midshaft Ulna Plate, 112mm
• 00841506114590: FreeFix Midshaft Radius Plate, 142mm
• 00841506114583: FreeFix Midshaft Radius Plate, 112mm
• 00841506114576: FreeFix Midshaft Radius Plate, 81mm
• 00841506113012: FreeFix Midshaft Radius Plate, 157mm
• 00841506112992: FreeFix Midshaft Radius Plate, 97mm
• 00841506112732: Drill Guide, FreeFix™, 2.7mm
• 00841506110011: Universal Bending Irons, 3.5mm
• 00841506109978: Forceps, Bone Holding Medium, Long Ratcheting
• 00841506108858: Drill, Solid Side Cutting, 2.5mm x 40mm (OUS)