Inion CompressOn™ Instrument IFS-6008

GUDID 06438408008092

Drill tap Ø 6.0 mm, cannulated

Inion Oy

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 06438408008092
• NIH Device Record Key: 3579ccc6-91bb-4f26-8788-981f5248ab29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion CompressOn™ Instrument
• Version Model Number: 1
• Catalog Number: IFS-6008
• 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: true
• 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
GS1	06438408008092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203105

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

[06438408008092]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

On-Brand Devices [Inion CompressOn™ Instrument]

• 06438408009723: Drill tap Ø 4.5 Cannulated, short
• 06438408009716: Drill tap Ø, 4.0 Cannulated, short
• 06438408009709: Drill Ø 3.2 Cannulated, short
• 06438408008948: K-wire Ø 2.0x230 mm
• 06438408008931: K-wire Ø 1.6x150 mm
• 06438408008924: K-wire Ø 1.25x150 mm
• 06438408008917: K-wire Ø 0.8x150 mm
• 06438408008900: Depth gauge for 150 mm K-wire
• 06438408008894: Depth gauge for 230 mm K-wire
• 06438408008115: Drill sleeve Ø4.2/6.0 mm, for Ø 6.0 mm screws
• 06438408008108: Drill sleeve Ø3.7/5.0 mm, for Ø 5.0 mm screws
• 06438408008092: Drill tap Ø 6.0 mm, cannulated
• 06438408008085: Drill tap Ø 5.0 mm, cannulated
• 06438408008061: Drill tap Ø 2.7 mm, cannulated
• 06438408008054: Drill Ø 4.2 mm, cannulated
• 06438408008047: Drill Ø 3.7 mm, cannulated
• 06438408008023: Drill Ø 2.0 mm, cannulated
• 06438408008016: Screwdriver shaft, T25
• 06438408008009: Screwdriver shaft, T15
• 06438408007996: Screwdriver shaft, T8
• 06438408007989: Screwdriver shaft, T7
• 06438408012013: CompressOn Headless Screw Tray