Inion S-2™ SPN-5423

GUDID 06438408007071

Plate, 37 mm (22 mm hole span)

Inion Oy

Spinal fixation plate, bioabsorbable

• Primary Device ID: 06438408007071
• NIH Device Record Key: 913f759b-8e5c-451d-9fb1-cd9ec7d110bc
• 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
GS1	06438408007071 [Secondary]
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: 3
• Public Version Date: 2023-09-18
• 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