Hinged Laminoplasty 174-908PP

GUDID 00190837103965

Bent 8mm Parallel Plate, Parallel Hinge

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837103965
• NIH Device Record Key: 6ed34c5b-6075-4fb2-9249-2abc4949bc4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hinged Laminoplasty
• Version Model Number: 174-908PP
• Catalog Number: 174-908PP
• 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	00190837103965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191927

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[00190837103965]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [Hinged Laminoplasty]

• 00190837104474: Installer
• 00190837104467: Driver
• 00190837104450: 11mm Drill
• 00190837104443: 9mm Drill
• 00190837104436: 7mm Drill
• 00190837104429: 5mm Drill
• 00190837104412: Plate Holder
• 00190837104405: Drill Guide
• 00190837104399: Plate Bender/Cutter
• 00190837104382: 9mm X 12mm Laminoplasty Spacer
• 00190837104375: 9mm X 10mm Laminoplasty Spacer
• 00190837104368: 9mm X 8mm Laminoplasty Spacer
• 00190837104351: 9mm X 6mm Laminoplasty Spacer
• 00190837104344: 9mm X 4mm Laminoplasty Spacer
• 00190837104337: Laminoplasty Coupling Screw
• 00190837104320: 7mm X 12mm Laminoplasty Spacer
• 00190837104313: 7mm X 10mm Laminoplasty Spacer
• 00190837104306: 7mm X 8mm Laminoplasty Spacer
• 00190837104290: 7mm X 6mm Laminoplasty Spacer
• 00190837104283: 7mm X 4mm Laminoplasty Spacer
• 00190837104276: 5mm X 12mm Laminoplasty Spacer
• 00190837104269: 5mm X 10mm Laminoplasty Spacer
• 00190837104252: 5mm X 8mm Laminoplasty Spacer
• 00190837104245: 5mm X 6mm Laminoplasty Spacer
• 00190837104238: 5mm X 4mm Laminoplasty Spacer
• 00190837104221: Retaining Laminoplasty Locking Screw, 3.0mm x 11mm
• 00190837104214: Retaining Laminoplasty Locking Screw, 3.0mm x 9mm
• 00190837104207: Retaining Laminoplasty Locking Screw, 3.0mm x 7mm
• 00190837104191: Retaining Laminoplasty Locking Screw, 3.0mm x 5mm
• 00190837104184: Retaining Laminoplasty Locking Screw, 2.4mm x 11mm
• 00190837104177: Retaining Laminoplasty Locking Screw, 2.4mm x 9mm
• 00190837104160: Retaining Laminoplasty Locking Screw, 2.4mm x 7mm
• 00190837104153: Retaining Laminoplasty Locking Screw, 2.4mm x 5mm
• 00190837104146: Bent 12mm Midline Plate, Hybrid Hinge
• 00190837104139: Bent 12mm Parallel Plate, Parallel Hinge
• 00190837104122: Bent 12mm Parallel Plate, Midline Hinge
• 00190837104115: Bent 12mm Parallel Plate, Hybrid Hinge
• 00190837104108: Bent 12mm Midline Plate, Parallel Hinge
• 00190837104092: Bent 12mm Midline Plate, Midline Hinge
• 00190837104085: Bent 10mm Midline Plate, Hybrid Hinge
• 00190837104078: Bent 12mm Hybrid Plate, Parallel Hinge
• 00190837104061: Bent 12mm Hybrid Plate, Midline Hinge
• 00190837104054: Bent 12mm Hybrid Plate, Hybrid Hinge
• 00190837104047: Bent 10mm Parallel Plate, Parallel Hinge
• 00190837104030: Bent 10mm Parallel Plate, Midline Hinge
• 00190837104023: Bent 10mm Parallel Plate, Hybrid Hinge
• 00190837104016: Bent 10mm Midline Plate, Parallel Hinge
• 00190837104009: Bent 10mm Midline Plate, Midline Hinge
• 00190837103996: Bent 10mm Hybrid Plate, Parallel Hinge
• 00190837103989: Bent 10mm Hybrid Plate, Midline Hinge