KinematX

GUDID 00842078111512

KinematX Radial Stem - Size 1; Sterile Packed

EXTREMITY MEDICAL, LLC

Total wrist prosthesis

• Primary Device ID: 00842078111512
• NIH Device Record Key: b76dc420-aa12-482c-b685-2438400953a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KinematX
• Version Model Number: 115-11000-S
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, LLC
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078111512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191525

FDA Product Code

• JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-04
• Device Publish Date: 2020-10-27

On-Brand Devices [KinematX]

• 00842078120019: Radial Body Assembly - RIGHT, +6
• 00842078120002: Radial Body Assembly - LEFT, +6
• 00842078119990: Radial Body Assembly - RIGHT, +4
• 00842078119983: Radial Body Assembly - LEFT, +4
• 00842078117033: 4.75 mm Locking Screw x 50
• 00842078117002: 4.75 mm Locking Screw x 45
• 00842078116999: 4.75 mm Locking Screw x 40
• 00842078116968: 4.75 mm Locking Screw x 35
• 00842078116937: 4.75 mm Locking Screw x 30
• 00842078116906: 4.75 mm Locking Screw x 25
• 00842078116876: 4.75 mm Locking Screw x 20
• 00842078116852: 4.75 mm Locking Screw x 15
• 00842078116838: Standard Baseplate, 15mm Stem
• 00842078116814: Standard Baseplate, 12mm Stem
• 00842078112090: Carpal Cap; Sterile Packed
• 00842078112045: Radial Body Assembly - RIGHT, +2
• 00842078112038: Radial Body Assembly - LEFT, +2
• 00842078112021: Radial Body Assembly - RIGHT, +0
• 00842078112014: Radial Body Assembly - LEFT, +0
• 00842078111536: KinematX Radial Stem - Size 3; Sterile Packed
• 00842078111529: KinematX Radial Stem - Size 2; Sterile Packed
• 00842078111512: KinematX Radial Stem - Size 1; Sterile Packed
• 00842078114612: KinematX Total Instrument Tray