L-Box®

GUDID M711LB1580

SST

Innovasis, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M711LB1580
• NIH Device Record Key: 1b559250-7d0b-4c1f-bbb0-8b2039e79d94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Box®
• Version Model Number: LB-158
• Company DUNS: 156567492
• Company Name: Innovasis, 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: false
• Serial Number: true
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LB1580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121581

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

[M711LB1580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [L-Box®]

• M711LB0100: SST
• M711LB1060: SST, Al
• M711LB1050: SST, Al
• M711LB1040: SST, Al
• M711LB1010: SST, Al
• M711LB1000: SST, Al
• M711LB0990: SST, Al
• M711LB0980: SST, Al
• M711LB0970: SST, Al
• M711LB0960: SST, Al
• M711XLC5514120: PEEK, Ti 6Al 4V (ELI)
• M711XLC5514070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5514000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5512120: PEEK, Ti 6Al 4V (ELI)
• M711XLC5512070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5512000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5510120: PEEK, Ti 6Al 4V (ELI)
• M711XLC5510070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5510000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5508070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5508000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5014120: PEEK, Ti 6Al 4V (ELI)
• M711XLC5014070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5014000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5012120: PEEK, Ti 6Al 4V (ELI)
• M711XLC5012070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5012000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5010120: PEEK, Ti 6Al 4V (ELI)
• M711XLC5010070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5010000: PEEK, Ti 6Al 4V (ELI)
• M711XLC5008070: PEEK, Ti 6Al 4V (ELI)
• M711XLC5008000: PEEK, Ti 6Al 4V (ELI)
• M711XLC4514120: PEEK, Ti 6Al 4V (ELI)
• M711XLC4514070: PEEK, Ti 6Al 4V (ELI)
• M711XLC4514000: PEEK, Ti 6Al 4V (ELI)
• M711XLC4512120: PEEK, Ti 6Al 4V (ELI)
• M711XLC4512070: PEEK, Ti 6Al 4V (ELI)
• M711XLC4512000: PEEK, Ti 6Al 4V (ELI)
• M711XLC4510120: PEEK, Ti 6Al 4V (ELI)
• M711XLC4510070: PEEK, Ti 6Al 4V (ELI)
• M711XLC4510000: PEEK, Ti 6Al 4V (ELI)
• M711XLC4508070: PEEK, Ti 6Al 4V (ELI)
• M711XLC4508000: PEEK, Ti 6Al 4V (ELI)
• M711XLB5514120: PEEK, Ti 6Al 4V (ELI)
• M711XLB5514070: PEEK, Ti 6Al 4V (ELI)
• M711XLB5514000: PEEK, Ti 6Al 4V (ELI)
• M711XLB5512120: PEEK, Ti 6Al 4V (ELI)
• M711XLB5512070: PEEK, Ti 6Al 4V (ELI)
• M711XLB5512000: PEEK, Ti 6Al 4V (ELI)
• M711XLB5510120: PEEK, Ti 6Al 4V (ELI)