Longbow Spinal System 85-1545-009X

GUDID 00190837029494

LONGBOW Expandable Lateral Spacer, 9mm x 45mm x 0°

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837029494
• NIH Device Record Key: 351fa1e0-3326-45aa-a254-0b2ccae0ed35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Longbow Spinal System
• Version Model Number: 85-1545-009X
• Catalog Number: 85-1545-009X
• 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	00190837029494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133717

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190837029494]

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: 2019-11-14

On-Brand Devices [Longbow Spinal System]

• 00190837005917: 85-1555-715X
• 00190837005900: 85-1555-713X
• 00190837005894: 85-1555-711X
• 00190837005887: 85-1555-709X
• 00190837005870: 85-1550-715X
• 00190837005863: 85-1550-713X
• 00190837005856: 85-1550-711X
• 00190837005849: 85-1550-709X
• 00190837005832: 85-1555-015X
• 00190837005825: 85-1555-013X
• 00190837005818: 85-1555-011X
• 00190837005801: 85-1555-009X
• 00190837005795: 85-1550-015X
• 00190837005788: 85-1550-013X
• 00190837005771: 85-1550-011X
• 00190837005764: 85-1550-009X
• 00190837061760: Modified Hudson Box Cutter, 15mm x 10mm
• 00190837061753: Modified Hudson Box Cutter, 15mm x 8mm
• 00190837061739: Cannula Plunger
• 00190837061722: Modular Trial, 15mm x 16mm
• 00190837061715: Modular Trial, 15mm x 14mm
• 00190837061692: Modular Trial, 15mm x 10mm
• 00190837061685: Modular Trial, 15mm x 9mm
• 00190837061661: Longbow Expandable Trial, 50mm
• 00190837061586: 50 x 9mm Housing
• 00190837061562: Longbow Extracting Plunger, Large Chamfer
• 00190837061548: Longbow Controlled Delivery Instrument
• 00190837061531: 55mm Expandable Trial
• 00190837061524: Longbow Expandable Trial
• 00190837061517: 45mm Expandable Trial
• 00190837062224: Pivoting Arm
• 00190837062217: Pivoting Arm
• 00190837062200: Pivoting Arm
• 00190837062194: Pivoting Arm
• 00190837062187: Pivoting Arm
• 00190837062170: 85-1540-012X
• 00190837062163: Screw
• 00190837062156: Pivoting Arm
• 00190837062149: Lordotic Longbow Trial, 15mm
• 00190837062132: Lordotic Longbow Trial, 13mm
• 00190837062125: Lordotic Longbow Trial, 11mm
• 00190837062118: Lordotic Longbow Trial, 9mm
• 00190837062101: Custom Distractor
• 00190837062095: Modified Hudson Shaper, 15mm
• 00190837062088: 13mm Plateau - X Shaper
• 00190837062071: 11mm Plateau - X Shaper
• 00190837062064: Modified Hudson Shaper, 9mm
• 00190837062057: 8mm Plateau - X Shaper
• 00190837062040: 7mm Plateau - X Shaper
• 00190837062033: Modified Hudson Box Cutter, 15mm