KARMA MIS

GUDID 00840606167956

Karma Tensioner

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00840606167956
• NIH Device Record Key: d910d174-5720-4d3e-9278-81d5cc047ffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KARMA MIS
• Version Model Number: 75695-000
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840606167956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190289

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

[00840606167956]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [KARMA MIS]

• 00840606169974: Awl Stylet
• 00840606169936: Karma® MIS Tray Base
• 00840606169929: Karma® MIS Tray Lower Level Insert
• 00840606169912: Karma® MIS Tray Top Level Insert
• 00840606169905: Karma® MIS Tray Lid
• 00840606169899: Karma® MIS Tray Assembly
• 00840606167956: Karma Tensioner