Inion S-1™ SPN-5210

GUDID M224SPN52109

4.5 x 12 mm screw

Inion Oy

Spinal bone screw, bioabsorbable

• Primary Device ID: M224SPN52109
• NIH Device Record Key: 229c7a4b-02ca-4f79-9e68-5c66c1b5efb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion S-1™
• Version Model Number: 1
• Catalog Number: SPN-5210
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• 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
HIBCC	M224SPN52109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051821

FDA Product Code

• OJB: Resorbable spinal intervertebral body fixation orthosis - plate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-02-07

On-Brand Devices [Inion S-1™]

• 06438408006944: 5.0 x 16 mm screw
• 06438408006937: 5.0 x 14 mm screw
• 06438408006920: 5.0 x 12 mm screw
• 06438408006913: 4.5 x 16 mm screw
• 06438408006906: 4.5 x 14 mm screw
• 06438408006890: 4.5 x 12 mm screw
• M224SPN52129: 4.5 x 16 mm screw
• M224SPN52119: 4.5 x 14 mm screw
• M224SPN52109: 4.5 x 12 mm screw
• M224SPN52059: 5.0 x 16 mm screw
• M224SPN52049: 5.0 x 14 mm screw
• M224SPN52039: 5.0 x 12 mm screw
• M224SPN52029: 4.5 x 16 mm screw (4 x)
• M224SPN52019: 4.5 x 14 mm screw (4 x)
• M224SPN52009: 4.5 x 12 mm screw (4 x)
• M224SPN50219: Plate, 48 x 19 x 2.0 mm
• M224SPN50209: Plate, 45 x 19 x 2.0 mm
• 06438408006869: Plate, 42 x 19 x 2.0 mm
• 06438408006852: Plate, 39 x 19 x 2.0 mm
• 06438408006845: Plate, 36 x 19 x 2.0 mm
• 06438408006838: Plate, 33 x 19 x 2.0 mm
• 06438408006821: Plate, 31 x 19 x 2.0 mm
• 06438408006814: Plate, 29 x 19 x 2.0 mm
• 06438408006807: Plate, 27 x 19 x 2.0 mm
• M224SPN50129: Plate, 25 x 19 x 2.0 mm
• M224SPN50119: Plate, 23 x 19 x 2.0 mm
• M224SPN50109: Plate, 21 x 19 x 2.0 mm
• M224SPN50079: Plate, 31 x 19 x 0.8 mm
• M224SPN50069: Plate, 29 x 19 x 0.8 mm
• M224SPN50059: Plate, 27 x 19 x 0.8 mm
• M224SPN50049: Plate, 25 x 19 x 0.8 mm
• M224SPN50039: Plate, 31 x 19 x 2.0 mm
• M224SPN50029: Plate, 29 x 19 x 2.0 mm
• M224SPN50019: Plate, 27 x 19 x 2.0 mm
• M224SPN50009: Plate, 25 x 19 x 2.0 mm
• M224SPN52259: 5.0 x 16 mm screw
• M224SPN52249: 5.0 x 14 mm screw
• M224SPN52239: 5.0 x 12 mm screw
• M224SPN52229: 4.5 x 16 mm screw
• M224SPN52219: 4.5 x 14 mm screw
• M224SPN52209: 4.5 x 12 mm screw
• M224SPN50199: Plate, 42 x 19 x 2.0 mm
• M224SPN50189: Plate, 39 x 19 x 2.0 mm
• M224SPN50179: Plate, 36 x 19 x 2.0 mm
• M224SPN50169: Plate, 33 x 19 x 2.0 mm
• M224SPN50159: Plate, 31 x 19 x 2.0 mm
• M224SPN50149: Plate, 29 x 19 x 2.0 mm
• M224SPN50139: Plate, 27 x 19 x 2.0 mm
• 06438408012303: 4.5 x 16 mm screw
• 06438408012297: 4.5 x 14 mm screw