Humeral Fixation Set FFC-35120-TS

GUDID 00841506130262

SKELETAL DYNAMICS L.L.C.

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00841506130262
• NIH Device Record Key: c07f1391-4619-48c0-aa45-0808cff37dd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humeral Fixation Set
• Version Model Number: Screw, FreeFix™ Compression, 3.5mm x 12mm, Ti
• Catalog Number: FFC-35120-TS
• 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
• 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
• 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	00841506130262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200367

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

[00841506130262]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-22

On-Brand Devices [Humeral Fixation Set]

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