Alphatec Solus

GUDID 00840967190488

Solus Straight Inserter

ALPHATEC SPINE, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00840967190488
• NIH Device Record Key: 252468e9-a4b4-454e-a352-50188e44030e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alphatec Solus
• Version Model Number: 25971
• 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
• 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
• 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	00840967190488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123993

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

[00840967190488]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [Alphatec Solus]

• 00844856099173: ALPHATEC SOLUS LUMBAR SPACER, 18mm LARGE, 12 LORDOTIC, STERILE
• 00844856099166: ALPHATEC SOLUS LUMBAR SPACER, 16mm LARGE, 12 LORDOTIC, STERILE
• 00844856099159: ALPHATEC SOLUS LUMBAR SPACER, 14mm LARGE, 12 LORDOTIC, STERILE
• 00844856099142: ALPHATEC SOLUS LUMBAR SPACER, 12mm LARGE, 12 LORDOTIC, STERILE
• 00844856099135: ALPHATEC SOLUS LUMBAR SPACER, 18mm LARGE, 7 LORDOTIC, STERILE
• 00844856099128: ALPHATEC SOLUS LUMBAR SPACER, 16mm LARGE, 7 LORDOTIC, STERILE
• 00844856099111: ALPHATEC SOLUS LUMBAR SPACER, 14mm LARGE, 7 LORDOTIC, STERILE
• 00844856099104: ALPHATEC SOLUS LUMBAR SPACER, 12mm LARGE, 7 LORDOTIC, STERILE
• 00844856099098: ALPHATEC SOLUS LUMBAR SPACER, 10mm LARGE, 7 LORDOTIC, STERILE
• 00844856099081: ALPHATEC SOLUS LUMBAR SPACER, 16mm MEDIUM, 12 LORDOTIC, STERILE
• 00844856099074: ALPHATEC SOLUS LUMBAR SPACER, 14mm MEDIUM, 12 LORDOTIC, STERILE
• 00844856099067: ALPHATEC SOLUS LUMBAR SPACER, 12mm MEDIUM, 12 LORDOTIC, STERILE
• 00844856099050: ALPHATEC SOLUS LUMBAR SPACER, 16mm MEDIUM, 7 LORDOTIC, STERILE
• 00844856099043: ALPHATEC SOLUS LUMBAR SPACER, 14mm MEDIUM, 7 LORDOTIC, STERILE
• 00844856099036: ALPHATEC SOLUS LUMBAR SPACER, 12mm MEDIUM, 7 LORDOTIC, STERILE
• 00844856099029: ALPHATEC SOLUS LUMBAR SPACER, 10mm MEDIUM, 7 LORDOTIC, STERILE
• 00844856062719: ALPHATEC SOLUS DISTAL WRENCH TIP
• 00844856054387: Solus Lumbar Inserter / Distractor
• 00840967190525: Solus Distal Deployment Wrench
• 00840967190488: Solus Straight Inserter
• 00840967190464: Solus, Lumbar Trial, Large, 18 mm, 12° Lordotic, Body
• 00840967190457: Solus, Lumbar Trial, Large, 16 mm, 12° Lordotic, Body
• 00840967190440: Solus, Lumbar Trial, Large, 14 mm, 12° Lordotic, Body
• 00840967190433: Solus, Lumbar Trial, Large, 12 mm, 12° Lordotic, Body
• 00840967190426: Solus, Lumbar Trial, Large, 18 mm, 7° Lordotic, Body
• 00840967190419: Solus, Lumbar Trial, Large, 16 mm, 7° Lordotic, Body
• 00840967190402: Solus, Lumbar Trial, Large, 14 mm, 7° Lordotic, Body
• 00840967190396: Solus, Lumbar Trial, Large, 12 mm, 7° Lordotic, Body
• 00840967190389: Solus, Lumbar Trial, Large, 10 mm, 7° Lordotic, Body
• 00840967190372: Solus, Lumbar Trial, Medium, 16 mm, 12° Lordotic, Body
• 00840967190365: Solus, Lumbar Trial, Medium, 14 mm, 12° Lordotic, Body
• 00840967190358: Solus, Lumbar Trial, Medium, 12 mm, 12° Lordotic, Body
• 00840967190341: Solus, Lumbar Trial, Medium, 16 mm, 7° Lordotic, Body
• 00840967190334: Solus, Lumbar Trial, Medium, 14 mm, 7° Lordotic, Body
• 00840967190327: Solus, Lumbar Trial, Medium, 12 mm, 7° Lordotic, Body
• 00840967190310: Solus, Lumbar Trial, Medium, 10 mm, 7° Lordotic, Body
• 00840967189239: Solus Proximal Deployment Wrench