KinematX

GUDID 00842078116838

Standard Baseplate, 15mm Stem

EXTREMITY MEDICAL, LLC

Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis

• Primary Device ID: 00842078116838
• NIH Device Record Key: bc8a9224-040e-4a87-83e6-532df58e1198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KinematX
• Version Model Number: 137-50015-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	00842078116838 [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