Inion S-2™ SPN-5423

GUDID M224SPN54239

Plate, 37 mm (22 mm hole span)

Inion Oy

Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable Spinal fixation plate, bioabsorbable

• Primary Device ID: M224SPN54239
• NIH Device Record Key: 913f759b-8e5c-451d-9fb1-cd9ec7d110bc
• Commercial Distribution Discontinuation: 2026-10-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion S-2™
• Version Model Number: 1
• Catalog Number: SPN-5423
• 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	M224SPN54239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151360

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: 2023-12-19
• Device Publish Date: 2018-03-26

On-Brand Devices [Inion S-2™]

• M224SPN55079: 6.7 x 31 mm screw
• M224SPN55069: 6.7 x 28 mm screw
• 06438408007149: 6.7 x 25 mm screw
• 06438408007132: 6.7 x 22 mm screw
• 06438408007125: 6.0 x 31 mm screw
• 06438408007118: 6.0 x 28 mm screw
• 06438408007101: 6.0 x 25 mm screw
• 06438408007095: 6.0 x 22 mm screw
• 06438408007088: Plate, 40 mm (25 mm hole span)
• 06438408007071: Plate, 37 mm (22 mm hole span)
• 06438408007064: Plate, 34 mm (19 mm hole span)
• 06438408007057: Plate, 31 mm (16 mm hole span)
• M224SPN54179: 70 x 35 x 4.5 mm Plate, 6 holes
• M224SPN54169: 120 x 80 x 0.75 mm Plate
• 06438408007040: Plate, 62 x 28 x 3.2 mm
• M224SPN54099: Plate, 59 x 28 x 3.2 mm
• M224SPN54089: Plate, 56 x 28 x 3.2 mm
• M224SPN54079: Plate, 53 x 28 x 3.2 mm
• 06438408007002: Plate, 50 x 28 x 3.2 mm
• 06438408006999: Plate, 49 x 28 x 3.2 mm
• 06438408006982: Plate, 46 x 28 x 3.2 mm
• 06438408006975: Plate, 43 x 28 x 3.2 mm
• 06438408006968: Plate, 40 x 28 x 3.2 mm
• 06438408006951: Plate, 37 x 28 x 3.2 mm
• M224SPN55059: 6.7 x 25 mm screw
• M224SPN55049: 6.7 x 22 mm screw
• M224SPN55039: 6.0 x 31 mm screw
• M224SPN55029: 6.0 x 28 mm screw
• M224SPN55019: 6.0 x 25 mm screw
• M224SPN55009: 6.0 x 22 mm screw
• M224SPN54249: Plate, 40 mm (25 mm hole span)
• M224SPN54239: Plate, 37 mm (22 mm hole span)
• M224SPN54229: Plate, 34 mm (19 mm hole span)
• M224SPN54219: Plate, 31 mm (16 mm hole span)
• M224SPN54109: Plate, 62 x 28 x 3.2 mm
• M224SPN54069: Plate, 50 x 28 x 3.2 mm
• M224SPN54059: Plate, 49 x 28 x 3.2 mm
• M224SPN54049: Plate, 46 x 28 x 3.2 mm
• M224SPN54039: Plate, 43 x 28 x 3.2 mm
• M224SPN54029: Plate, 40 x 28 x 3.2 mm
• M224SPN54019: Plate, 37 x 28 x 3.2 mm
• 06438408012327: 70 x 35 x 4.5 mm Plate, 6 holes
• 06438408012310: 120 x 80 x 0.75 mm Plate
• 06438408007163: 6.7 x 31 mm screw
• 06438408007156: 6.7 x 28 mm screw
• 06438408007033: Plate, 59 x 28 x 3.2 mm
• 06438408007026: Plate, 56 x 28 x 3.2 mm
• 06438408007019: Plate, 53 x 28 x 3.2 mm