Valence Robotic Navigation System

GUDID 00190376540528

8.5 mm Tap, Power, Robot

ALPHATEC SPINE, INC.

Bone tap, reusable

• Primary Device ID: 00190376540528
• NIH Device Record Key: 2ffdf4ef-658a-41bf-ae16-423aa6d368a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valence Robotic Navigation System
• Version Model Number: 525-17039-085-RJ
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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: 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(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376540528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232413

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

[00190376540528]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [Valence Robotic Navigation System]

• 00190376647852: Valence Robot Alpha Core Inst. M
• 00190376647845: Valence Robot Alpha Stimulating Inst. S
• 00190376647838: Valence Robot Alpha Stimulating Inst. M
• 00190376647821: Valence Robot Alpha Core Inst. S
• 00190376643809: Valence Robot Alpha Fixation Inst.
• 00190376585659: Slap Hammer, Small
• 00190376560274: Scalpel Handle, NM, Robot
• 00190376560267: Scalpel Handle, Robot
• 00190376560250: Tissue Protector, S Smooth, NM
• 00190376560243: Tissue Protector, S Teeth, NM
• 00190376560236: Tissue Protector, M Smooth, NM
• 00190376560229: Tissue Protector, M Teeth, NM
• 00190376560212: Open Reduction Screw Clip On
• 00190376541440: TP Dilator, S Conical Tip, Robot
• 00190376541433: TP Dilator, S Bullet Awl Tip, Robot
• 00190376541402: TP Dilator, M Conical Tip, Robot
• 00190376541396: TP Dilator, M Bullet Awl Tip, Robot
• 00190376541372: Tissue Protector, S Smooth
• 00190376541365: Tissue Protector, S Teeth
• 00190376541358: Tissue Protector, M Smooth
• 00190376541341: Tissue Protector, M Teeth
• 00190376541334: Awl Tap Cap
• 00190376541327: Awl, Robot
• 00190376541310: Insulating Sleeve, NM, Robot
• 00190376541211: 7.2mm Drill, Power, Robot
• 00190376541204: 7.2mm Drill, Robot
• 00190376541198: 6.9mm Drill, Power, Robot
• 00190376541181: 6.9mm Drill, Robot
• 00190376541174: 6.6mm Drill, Power, Robot
• 00190376541167: 6.6mm Drill, Robot
• 00190376541150: 6.2mm Drill, Power, Robot
• 00190376541143: 6.2mm Drill, Robot
• 00190376541136: 5.9mm Drill, Power, Robot
• 00190376541129: 5.9mm Drill, Robot
• 00190376541112: 5.5mm Drill, Power, Robot
• 00190376541105: 5.5mm Drill, Robot
• 00190376541099: 5.2mm Drill, Power, Robot
• 00190376541082: 5.2mm Drill, Robot
• 00190376541075: 4.8mm Drill, Power, Robot
• 00190376541068: 4.8mm Drill, Robot
• 00190376541051: 4.5mm Drill, Power, Robot
• 00190376541044: 4.5mm Drill, Robot
• 00190376541037: 4.1mm Drill, Power, Robot
• 00190376541020: 4.1mm Drill, Robot
• 00190376541013: 3.8mm Drill, Power, Robot
• 00190376541006: 3.8mm Drill, Robot
• 00190376540993: 3.5mm Drill, Power, Robot
• 00190376540986: 3.5mm Drill, Robot
• 00190376540979: 3.1mm Drill, Power, Robot
• 00190376540962: 3.1mm Drill, Robot