Geminus SPLS-20160-TS

GUDID 00841506102979

SKELETAL DYNAMICS L.L.C.

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

• Primary Device ID: 00841506102979
• NIH Device Record Key: 464c5724-2e28-4ef6-9379-2486eae6e58e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geminus
• Version Model Number: Smooth Peg, Locking, 2.0mm x 16mm, Ti
• Catalog Number: SPLS-20160-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

Device Dimensions

• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506102979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111620

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-30

On-Brand Devices [Geminus]

• 00841506109077: Drill, 2.0mm x 127mm
• 00841506105703: Assembled, GEMINUS Volar Distal Radius Plate, Stan
• 00841506105697: Assembled, GEMINUS Volar Distal Radius Plate, Stan
• 00841506105680: Assembled, GEMINUS Volar Distal Radius Plate, Stan
• 00841506105673: Assembled, GEMINUS Volar Distal Radius Plate, Stan
• 00841506105666: Assembled, GEMINUS Volar Distal Radius Plate, Stan
• 00841506105659: Assembled, GEMINUS Volar Distal Radius Plate, Stan
• 00841506105642: GEMINUS VDR Plate, Standard, 7 Hole, Left
• 00841506105635: GEMINUS VDR Plate, Standard, 7 Hole, Right
• 00841506105628: GEMINUS VDR Plate, Standard, 4 Hole, Left
• 00841506105611: GEMINUS VDR Plate, Standard, 4 Hole, Right
• 00841506105604: GEMINUS VDR Plate, Narrow, 4 Hole, Left
• 00841506105598: GEMINUS VDR Plate, Narrow, 4 Hole, Right
• 00841506105581: GEMINUS Volar Distal Radius Plate System - Instrum
• 00841506105574: GEMINUS Volar Distal Radius Plate System - Implant
• 00841506105567: Pre-Loaded Drill Guide, 2.0mm (Green)
• 00841506105550: Pre-Loaded Drill Guide, 2.0mm (Magenta)
• 00841506105543: Reusable Compression Screw, 2.7mm
• 00841506105536: Pre-Loaded Drill Guide, 2.0mm (Blue)
• 00841506105529: GEMINUS VDR Plate, Wide, 4 Hole, Left
• 00841506105512: GEMINUS VDR Plate, Wide, 4 Hole, Right
• 00841506105505: GEMINUS VDR Plate, Standard, 3 Hole, Left
• 00841506105499: GEMINUS VDR Plate, Standard, 3 Hole, Right
• 00841506105482: GEMINUS VDR Plate, Narrow, 3 Hole, Left
• 00841506105475: GEMINUS VDR Plate, Narrow, 3 Hole, Right
• 00841506105468: GEMINUS Select Instrument Tray
• 00841506105451: GEMINUS Select Implant Tray
• 00841506105406: Handle, AO QC, Fixed
• 00841506103730: Washer, Button
• 00841506103624: Threaded Peg, Non-Locking, 2.7mm x 32mm, Ti
• 00841506103617: Threaded Peg, Non-Locking, 2.7mm x 30mm, Ti
• 00841506103600: Threaded Peg, Non-Locking, 2.7mm x 28mm, Ti
• 00841506103594: Threaded Peg, Non-Locking, 2.7mm x 26mm, Ti
• 00841506103587: Threaded Peg, Non-Locking, 2.7mm x 24mm, Ti
• 00841506103570: Threaded Peg, Non-Locking, 2.7mm x 22mm, Ti
• 00841506103563: Threaded Peg, Non-Locking, 2.7mm x 20mm, Ti
• 00841506103556: Threaded Peg, Non-Locking, 2.7mm x 18mm, Ti
• 00841506103549: Threaded Peg, Non-Locking, 2.7mm x 16mm, Ti
• 00841506103532: Threaded Peg, Non-Locking, 2.7mm x 14mm, Ti
• 00841506103525: Threaded Peg, Non-Locking, 2.7mm x 12mm, Ti
• 00841506103518: Threaded Peg, Non-Locking, 2.7mm x 10mm, Ti
• 00841506103501: Threaded Peg, Locking, 2.3mm x 32mm, Ti
• 00841506103495: Threaded Peg, Locking, 2.3mm x 30mm, Ti
• 00841506103488: Threaded Peg, Locking, 2.3mm x 28mm, Ti
• 00841506103471: Threaded Peg, Locking, 2.3mm x 26mm, Ti
• 00841506103464: Threaded Peg, Locking, 2.3mm x 24mm, Ti
• 00841506103457: Threaded Peg, Locking, 2.3mm x 23mm, Ti
• 00841506103440: Threaded Peg, Locking, 2.3mm x 22mm, Ti
• 00841506103433: Threaded Peg, Locking, 2.3mm x 21mm, Ti
• 00841506103426: Threaded Peg, Locking, 2.3mm x 20mm, Ti