Align ALN-RHA-SYS

GUDID 00841506100753

SKELETAL DYNAMICS L.L.C.

Elbow radius prosthesis

• Primary Device ID: 00841506100753
• NIH Device Record Key: ff9aad59-e21b-4579-abc8-f6582e398093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Align
• Version Model Number: ALIGN Radial Head System
• Catalog Number: ALN-RHA-SYS
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506100753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092721

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

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: 2015-10-24

On-Brand Devices [Align]

• 00841506102092: Driver Extraction Tool
• 00841506101347: Driver, Universal QC, T-20
• 00841506101064: ALIGN, Trial, Radial Stem, 11.0mm
• 00841506101057: ALIGN, Trial, Radial Stem, 10.0mm
• 00841506101040: ALIGN, Trial, Radial Stem, 9.0mm
• 00841506101033: ALIGN, Trial, Radial Stem, 8.0mm
• 00841506101026: ALIGN, Trial, Radial Stem, 7.0mm
• 00841506101019: ALIGN, Stem Impactor
• 00841506101002: ALIGN, Radial Rasp, Stem 11.0mm
• 00841506100999: ALIGN, Radial Rasp, Stem 10.0mm
• 00841506100982: ALIGN, Radial Rasp, Stem 9.0mm
• 00841506100975: ALIGN, Radial Rasp, Stem 8.0mm
• 00841506100968: ALIGN, Radial Rasp, Stem 7.0mm
• 00841506100951: ALIGN, Radial Planer, Stem 11.0mm
• 00841506100944: ALIGN, Radial Planer, Stem 10.0mm
• 00841506100937: ALIGN, Radial Planer, Stem 9.0mm
• 00841506100920: ALIGN, Radial Planer, Stem 8.0mm
• 00841506100913: ALIGN, Radial Planer, Stem 7.0mm
• 00841506100906: ALIGN, Trial, Radial Neck, 8.0mm
• 00841506100890: ALIGN, Trial, Radial Neck, 6.0mm
• 00841506100883: ALIGN, Trial, Radial Neck, 4.0mm
• 00841506100876: ALIGN, Trial, Radial Neck, 2.0mm
• 00841506100869: ALIGN, Trial, Radial Neck, 0.0mm
• 00841506100852: ALIGN, Trial, Radial Head, 26mm
• 00841506100845: ALIGN, Trial, Radial Head, 24mm
• 00841506100838: ALIGN, Trial, Radial Head, 22mm
• 00841506100821: ALIGN, Trial, Radial Head, 20mm
• 00841506100814: ALIGN, Trial, Radial Head, 18mm
• 00841506100807: ALIGN, Sizer, Radial Head Implant
• 00841506100791: ALIGN, Head Alignment Tool, Radial Head Guide
• 00841506100784: Captive Rail & Axis Jig, Radial Head Guide
• 00841506100777: ALIGN, Bone Holding Forceps
• 00841506100760: ALIGN, Torque Handle, Radial Head
• 00841506100753: ALIGN Radial Head System
• 00841506100746: ALIGN, Neck Gauge & Head Inserter, 8mm
• 00841506100739: ALIGN, Neck Gauge & Head Inserter, 6mm
• 00841506100722: ALIGN, Neck Gauge & Head Inserter, 4mm
• 00841506100715: ALIGN, Neck Gauge & Head Inserter, 2mm
• 00841506100708: ALIGN, Neck Gauge & Head Inserter, 0mm
• 00841506100586: ALIGN, Trials Caddy
• 00841506100579: ALIGN, Instrument Tray, Insert
• 00841506100562: ALIGN, Sterilization Tray, Lid
• 00841506100555: ALIGN, Sterilization Tray, Base
• 00841506100548: ALIGN Sterilization Tray, Assembly
• 00841506100302: ALIGN Radial Stem, 11mm x 8mm
• 00841506100296: ALIGN Radial Stem, 11mm x 6mm
• 00841506100289: ALIGN Radial Stem, 11mm x 4mm
• 00841506100272: ALIGN Radial Stem, 11mm x 2mm
• 00841506100265: ALIGN Radial Stem, 11mm x 0mm
• 00841506100258: ALIGN Radial Stem, 12mm x 8mm