Resolute 128-2-1221

GUDID 00190837071462

12mm x 21mm Threaded Cage Two Slot SC

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837071462
• NIH Device Record Key: 0c66f5e4-aa6c-424f-a6b3-7281acc4d618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resolute
• Version Model Number: 128-2-1221
• Catalog Number: 128-2-1221
• Company DUNS: 183641617
• Company Name: Life 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837071462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181625

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190837071462]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-07

On-Brand Devices [Resolute]

• 00190837085544: 18mm Double Barrel Guide Impaction Cap
• 00190837085520: 14mm Double Barrel Guide Impaction Cap
• 00190837071790: 18mm Threaded Cage Drill
• 00190837071783: 16mm Threaded Cage Drill
• 00190837071776: 14mm Threaded Cage Drill
• 00190837071769: 12mm Threaded Cage Drill
• 00190837071738: 16mm Threaded Cage Double Barrel Guide
• 00190837085537: 16mm Double Barrel Guide Impaction Cap
• 00190837085513: 12mm Double Barrel Guide Impaction Cap
• 00190837071752: 18mm x 21mm Threaded Cage SC
• 00190837071745: 18mm Threaded Cage Double Barrel Guide
• 00190837071721: 14mm Threaded Cage Double Barrel Guide
• 00190837071714: 12mm Threaded Cage Double Barrel Guide
• 00190837071707: Hex Driver Small T-Handle
• 00190837071691: 18mm Threaded Cage Installer
• 00190837071684: 16mm Threaded Cage Installer
• 00190837071677: 14mm Threaded Cage Installer
• 00190837071660: 12mm Threaded Cage Installer
• 00190837071653: 18mm Threaded Cage Installer Shaft
• 00190837071646: 16mm Threaded Cage Installer Shaft
• 00190837071639: 14mm Threaded Cage Installer Shaft
• 00190837071622: 12mm Threaded Cage Installer Shaft
• 00190837071615: 18mm Threaded Cage Tap
• 00190837071608: 16mm Threaded Cage Tap
• 00190837071592: 14mm Threaded Cage Tap
• 00190837071585: 12mm Threaded Cage Tap
• 00190837071578: 18mm Threaded Cage Cap
• 00190837071561: 16mm Threaded Cage Cap
• 00190837071554: 14mm Threaded Cage Cap
• 00190837071547: 12mm Threaded Cage Cap
• 00190837071530: 18mm x 25mm Threaded Cage Two Slot SC
• 00190837071523: 18mm x 21mm Threaded Cage Two Slot SC
• 00190837071516: 16mm x 25mm Threaded Cage Two Slot SC
• 00190837071509: 16mm x 21mm Threaded Cage Two Slot SC
• 00190837071493: 14mm x 25mm Threaded Cage Two Slot SC
• 00190837071486: 14mm x 21mm Threaded Cage Two Slot SC
• 00190837071479: 12mm x 25mm Threaded Cage Two Slot SC
• 00190837071462: 12mm x 21mm Threaded Cage Two Slot SC
• 00190837071455: 18mm x 25mm Threaded Cage Two Slot
• 00190837071448: 18mm x 21mm Threaded Cage Two Slot
• 00190837071431: 16mm x 25mm Threaded Cage Two Slot
• 00190837071424: 16mm x 21mm Threaded Cage Two Slot
• 00190837071417: 14mm x 25mm Threaded Cage Two Slot
• 00190837071400: 14mm x 21mm Threaded Cage Two Slot
• 00190837071394: 12mm x 25mm Threaded Cage Two Slot
• 00190837071387: 12mm x 21mm Threaded Cage Two Slot
• 00190837071370: ABCS 18mm Cylindrical Cage
• 00190837071363: ABCS 16mm Cylindrical Cage
• 00190837071356: ABCS 14mm Cylindrical Cage
• 00190837071349: ABCS 12mm Cylindrical Cage