Humeral Plating System FFLS-45240-TS

GUDID 00841506111186

SKELETAL DYNAMICS L.L.C.

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

• Primary Device ID: 00841506111186
• NIH Device Record Key: 35659608-2dd0-4f08-943f-3bd5d59f30b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humeral Plating System
• Version Model Number: Screw, Locking, FreeFix, 4.5mm x 24mm, Ti
• Catalog Number: FFLS-45240-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506111186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200367

FDA Product Code

• HWC: Screw, 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 [Humeral Plating System]

• 00841506116303: Humeral Plating Set Tray A
• 00841506115894: Depth Gauge, MT, 80mm
• 00841506115818: Countersink, 6.5mm
• 00841506115801: Drill, 3.2mm / 4.5mm
• 00841506115764: Thread-In Drill Guide, FreeFix, 4.5mm
• 00841506115696: Distal Trochlea Compression Screw, 3.5mm x 80mm, T
• 00841506115689: Distal Trochlea Compression Screw, 3.5mm x 75mm, T
• 00841506115672: Distal Trochlea Compression Screw, 3.5mm x 70mm, T
• 00841506115665: Distal Trochlea Compression Screw, 3.5mm x 65mm, T
• 00841506115641: Distal Trochlea Compression Screw, 3.5mm x 55mm, T
• 00841506115634: Distal Trochlea Compression Screw, 3.5mm x 50mm, T
• 00841506115610: Distal Trochlea Compression Screw, 3.5mm x 40mm, T
• 00841506114989: Drill, 2.0mm x 80mm
• 00841506114842: Hohmann Retractor, Large
• 00841506114811: Bending Rod, DHP
• 00841506114729: K-Wire, Single Trocar, 1.5 mm x 229 mm
• 00841506114699: Universal Bending Irons, 4.5mm
• 00841506112527: Distal Humerus Plate, Lateral Direct, 175mm, Left
• 00841506112510: Distal Humerus Plate, Lateral Direct, 175mm, Right
• 00841506112503: Distal Humerus Plate, Lateral Direct, 145mm, Left
• 00841506112480: Distal Humerus Plate, Lateral Direct, 115mm, Left
• 00841506112435: Drill, Cannulated, 3.7mm x 80mm
• 00841506111544: Midshaft Humerus Plate, Narrow 244mm
• 00841506111537: Midshaft Humerus Plate, Narrow 208mm
• 00841506111520: Midshaft Humerus Plate, Narrow 172mm
• 00841506111513: Midshaft Humerus Plate, Narrow 136mm
• 00841506111506: Midshaft Humerus Plate, Broad 244mm
• 00841506111483: Midshaft Humerus Plate, Broad 172mm
• 00841506111469: Drill Guide, FreeFix™, HPS
• 00841506111445: Driver, Universal, T15
• 00841506111407: Screw, Compression, 4.5mm x 34mm, Ti
• 00841506111391: Screw, Compression, 4.5mm x 32mm, Ti
• 00841506111384: Screw, Compression, 4.5mm x 30mm, Ti
• 00841506111377: Screw, Compression, 4.5mm x 28mm, Ti
• 00841506111360: Screw, Compression, 4.5mm x 26mm, Ti
• 00841506111353: Screw, Compression, 4.5mm x 24mm, Ti
• 00841506111339: Screw, Compression, 4.5mm x 20mm, Ti
• 00841506111322: Screw, Compression, 4.5mm x 18mm, Ti
• 00841506111315: Screw, Compression, 4.5mm x 16mm, Ti
• 00841506111308: Screw, Compression, 4.5mm x 14mm, Ti
• 00841506111230: Screw, Locking, FreeFix, 4.5mm x 34mm, Ti
• 00841506111223: Screw, Locking, FreeFix, 4.5mm x 32mm, Ti
• 00841506111216: Screw, Locking, FreeFix, 4.5mm x 30mm, Ti
• 00841506111209: Screw, Locking, FreeFix, 4.5mm x 28mm, Ti
• 00841506111193: Screw, Locking, FreeFix, 4.5mm x 26mm, Ti
• 00841506111186: Screw, Locking, FreeFix, 4.5mm x 24mm, Ti
• 00841506111179: Screw, Locking, FreeFix, 4.5mm x 22mm, Ti
• 00841506111162: Screw, Locking, FreeFix, 4.5mm x 20mm, Ti
• 00841506111155: Screw, Locking, FreeFix, 4.5mm x 18mm, Ti
• 00841506111148: Screw, Locking, FreeFix, 4.5mm x 16mm, Ti