Navigated Instruments 121-A011-65

GUDID 00195860026601

6.5 TAP TROCAR TIP

Evolution Spine LLC

Bone tap, reusable

• Primary Device ID: 00195860026601
• NIH Device Record Key: c181f4ad-81cd-4bf6-a77a-95f7e6562bb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Instruments
• Version Model Number: 121-A011-65
• Catalog Number: 121-A011-65
• Company DUNS: 116940934
• Company Name: Evolution Spine 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: 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(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860026601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250167

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

[00195860026601]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-29

On-Brand Devices [Navigated Instruments]

• 00195860027042: COMMON TRAY LID
• 00195860027035: 8.5 TAP CANNULATED
• 00195860027028: 8.5 TAP TROCAR TIP
• 00195860026878: SHANK INSERTER CANNULATED
• 00195860026861: NAVIGATED INSTRUMENTS STOWE MIS SET TAG
• 00195860026854: NAVIGATED INSTRUMENTS STOWE MIS SYSTEM TAG
• 00195860026847: NAVIGATED INSTRUMENTS WHISTLER / STOWE SET TAG
• 00195860026830: NAVIGATED INSTRUMENTS WHISTLER / STOWE SYSTEM TAG
• 00195860026823: NAVIGATED INSTRUMENTS PEDICLE SCREW TRAY
• 00195860026816: STO POLY MIS CANNULATED
• 00195860026809: STO POLY REDUX CANNULATED
• 00195860026793: PROBE STRAIGHT LENKE
• 00195860026786: PROBE PADDLE
• 00195860026779: AWL TROCAR
• 00195860026762: AWL
• 00195860026755: WHI POLY LOW CANNULATED
• 00195860026748: WHI POLY REDUX/MIS CANNULATED
• 00195860026731: 10.5 TAP CANNULATED
• 00195860026724: 9.5 TAP CANNULATED
• 00195860026717: 8.5 TAP CANNULATED
• 00195860026700: 7.5 TAP CANNULATED
• 00195860026694: 6.5 TAP CANNULATED
• 00195860026687: 5.5 TAP CANNULATED
• 00195860026670: 4.75 TAP CANNULATED
• 00195860026663: 4.5 TAP CANNULATED
• 00195860026656: 3.75 TAP CANNULATED
• 00195860026649: 10.5 TAP TROCAR TIP
• 00195860026632: 9.5 TAP TROCAR TIP
• 00195860026625: 8.5 TAP TROCAR TIP
• 00195860026618: 7.5 TAP TROCAR TIP
• 00195860026601: 6.5 TAP TROCAR TIP
• 00195860026595: 5.5 TAP TROCAR TIP
• 00195860026588: 4.75 TAP TROCAR TIP
• 00195860026571: 4.5 TAP TROCAR TIP
• 00195860026564: 3.75 TAP TROCAR TIP