Inion S-2 instrument INS-9578

GUDID M224INS95789

Plate holder, angled

Inion Oy

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: M224INS95789
• NIH Device Record Key: 43f3a664-a3c5-42e9-a436-1867e7a40b33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion S-2 instrument
• Version Model Number: 0
• Catalog Number: INS-9578
• Company DUNS: 367994657
• Company Name: Inion Oy
• 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: 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	M224INS95789 [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

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

[M224INS95789]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Inion S-2 instrument]

• M224INS95789: Plate holder, angled
• M224INS957810: Plate holder, angled
• M224INS95779: Plate holder, straight
• M224INS957710: Plate holder, straight
• M224C609: Plate holder
• M224C6010: Plate holder
• M224ACC98429: Sterilization tray for instruments
• M224ACC984210: Sterilization tray for instruments
• M224INS95769: Bone tap 6.7 mm with stop for 31 mm screw
• M224INS957610: Bone tap 6.7 mm with stop for 31 mm screw
• M224INS95759: Bone tap 6.7 mm with stop for 28 mm screw
• M224INS957510: Bone tap 6.7 mm with stop for 28 mm screw
• M224INS95749: Bone tap 6.7 mm with stop for 25 mm screw
• M224INS957410: Bone tap 6.7 mm with stop for 25 mm screw
• M224INS95739: Bone tap 6.7 mm with stop for 22 mm screw
• M224INS957310: Bone tap 6.7 mm with stop for 22 mm screw
• M224INS95729: Bone tap 6.0 mm with stop for 31 mm screw
• M224INS957210: Bone tap 6.0 mm with stop for 31 mm screw
• M224INS95719: Bone tap 6.0 mm with stop for 27 mm screw
• M224INS957110: Bone tap 6.0 mm with stop for 27 mm screw
• M224INS95709: Bone tap 6.0 mm with stop for 25 mm screw
• M224INS957010: Bone tap 6.0 mm with stop for 25 mm screw
• M224INS95699: Bone tap 6.0 mm with stop for 22 mm screw
• M224INS956910: Bone tap 6.0 mm with stop for 22 mm screw
• 06438408007613: Drill Tap 6.0 / 25 mm