IMPlate IMP-WC-0215

GUDID 00841506102351

SKELETAL DYNAMICS L.L.C.

Arthrodesis nail, non-sterile

• Primary Device ID: 00841506102351
• NIH Device Record Key: 54cd571e-7637-46f1-af12-d9c44165ef1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPlate
• Version Model Number: IMPLATE Connector, 2mm x 15°
• Catalog Number: IMP-WC-0215
• 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

Device Dimensions

• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506102351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092720

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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 [IMPlate]

• 00841506104645: IMPLATE Connector, 12mm x 10°
• 00841506104638: IMPLATE Connector, 12mm x 5°
• 00841506104621: IMPLATE Connector, 7mm x 10°
• 00841506104614: IMPLATE Connector, 7mm x 5°
• 00841506104607: IMPLATE Connector, 2mm x 10°
• 00841506104591: IMPLATE Connector, 2mm x 5°
• 00841506103709: Unicortical Screw, 2.8mm x 14.0mm, Ti
• 00841506103693: Unicortical Screw, 2.8mm x 12.0mm, Ti
• 00841506103686: Unicortical Screw, 2.8mm x 10.0mm, Ti
• 00841506103679: Unicortical Screw, 2.8mm x 8.0mm, Ti
• 00841506103662: Unicortical Screw, 2.8mm x 7.0mm, Ti
• 00841506103655: Unicortical Screw, 2.8mm x 6.0mm, Ti
• 00841506103648: Unicortical Screw, 2.8mm x 5.0mm, Ti
• 00841506103631: Unicortical Screw, 2.8mm x 4.0mm, Ti
• 00841506103105: Set Screw, 3.0mm x 2.0mm, CoCr
• 00841506102443: IMPLATE Connector, 12mm x 22.5°
• 00841506102436: IMPLATE Connector, 12mm x 15°
• 00841506102429: IMPLATE Connector, 12mm x 7.5°
• 00841506102412: IMPLATE Connector, 12mm x 0°
• 00841506102405: IMPLATE Connector, 7mm x 22.5°
• 00841506102399: IMPLATE Connector, 7mm x 15°
• 00841506102382: IMPLATE Connector, 7mm x 7.5°
• 00841506102375: IMPLATE Connector, 7mm x 0°
• 00841506102368: IMPLATE Connector, 2mm x 22.5°
• 00841506102351: IMPLATE Connector, 2mm x 15°
• 00841506102344: IMPLATE Connector, 2mm x 7.5°
• 00841506102337: IMPLATE Connector, 2mm x 0°
• 00841506102320: IMPLATE Wrist Arthrodesis Nail System
• 00841506102313: IMPLATE Spreader, Wrist Arthrodesis Nails
• 00841506102306: IMPLATE Rasp 2, Distal Radius, 7.0mm x 70mm
• 00841506102290: IMPLATE Rasp 1, Distal Radius, 5.5mm x 70mm
• 00841506102283: IMPLATE Reamer 5, Metacarpal, 5.0mm x 87mm
• 00841506102276: IMPLATE Reamer 4, Metacarpal, 4.5mm x 87mm
• 00841506102269: IMPLATE Reamer 3, Metacarpal, 4.0mm x 87mm
• 00841506102252: IMPLATE Reamer 2, Metacarpal, 3.4mm x 87mm
• 00841506102245: IMPLATE Reamer 1, Metacarpal, 2.7mm x 87mm
• 00841506102238: IMPLATE, Minimum Gap Gauge
• 00841506102221: IMPLATE Awl, Wrist Arthrodesis Nails
• 00841506102214: IMPLATE Lock Screw, Unicort. Drill Guide
• 00841506102207: IMPLATE Uni Drill Guide, Drill Sleeve
• 00841506102191: IMPLATE Uni Drill Guide, DRMC Nails
• 00841506102184: IMPLATE Uni Drill Guide, Depth Gauge
• 00841506102177: IMPLATE Nail, Metacarpal, Standard, 4.6mm
• 00841506102160: IMPLATE Nail, Metacarpal, Standard, 4.0mm
• 00841506102153: IMPLATE Nail, Metacarpal, Mini
• 00841506102146: IMPLATE Rasp, Flaring and Troughing
• 00841506102139: IMPLATE Drill, Unicortical 3mm x 41mm
• 00841506102122: IMPLATE Nail, Distal Radius, Short, Ti
• 00841506102115: IMPLATE Nail, Distal Radius, Long, Ti
• 00841506102061: Handle, Mini Quick Connect, Fixed