Inion S-1 instrument INS-9527

GUDID M224INS95279

Temporary fixation screw

Inion Oy

Orthopaedic fixation implant alignment tool

• Primary Device ID: M224INS95279
• NIH Device Record Key: 5ec7a331-9806-4eba-ac0d-867c828981f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion S-1 instrument
• Version Model Number: 0
• Catalog Number: INS-9527
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
HIBCC	M224INS95279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071810

FDA Product Code

• OJB: Resorbable spinal intervertebral body fixation orthosis - plate

Sterilization

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

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

[M224INS95279]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-02
• Device Publish Date: 2016-08-31

On-Brand Devices [Inion S-1 instrument]

• M224INS95569: Plate holder
• M224INS955610: Plate holder
• M224ACC98419: Sterilization tray for instruments
• M224ACC984110: Sterilization tray for instruments
• M224INS952710: Temporary fixation screw
• M224INS95279: Temporary fixation screw
• M224INS95519: Bone tap 5.0 mm with stop for 16 mm screw
• M224INS955110: Bone tap 5.0 mm with stop for 16 mm screw
• M224INS95509: Bone tap 5.0 mm with stop for 14 mm screw
• M224INS955010: Bone tap 5.0 mm with stop for 14 mm screw
• M224INS95499: Bone tap 5.0 mm with stop for 12 mm screw
• M224INS954910: Bone tap 5.0 mm with stop for 12 mm screw
• M224INS95489: Bone tap 4.5 mm with stop for 16 mm screw
• M224INS954810: Bone tap 4.5 mm with stop for 16 mm screw
• M224INS95479: Bone tap 4.5 mm with stop for 14 mm screw
• M224INS954710: Bone tap 4.5 mm with stop for 14 mm screw
• M224INS95469: Bone tap 4.5 mm with stop for 12 mm screw
• M224INS954610: Bone tap 4.5 mm with stop for 12 mm screw