Inion FreedomPin™ OPK-15K1

GUDID 06438408004339

Pin kit 1.5 mm (2+1 pcs)

Inion Oy

Orthopaedic bone pin, bioabsorbable

• Primary Device ID: 06438408004339
• NIH Device Record Key: c8e4af1b-8ae6-4aef-bcfb-a3b9597da97e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion FreedomPin™
• Version Model Number: 1
• Catalog Number: OPK-15K1
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	06438408004339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133932

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [Inion FreedomPin™]

• M224OPK20K39: Pin kit 2.0 mm (3 pcs)
• M224OPK20K29: Pin Kit 2.0 mm (2 pcs)
• M224OPK20K19: Pin kit 2.0 mm (2+1 pcs)
• M224OPK15K39: Pin kit 1.5 mm (3 pcs)
• M224OPK15K29: Pin kit 1.5 mm (2 pcs)
• M224OPK15K19: Pin kit 1.5 mm (2+1 pcs)
• M224OPA32709: Pin 3.2 x 70 mm
• M224OPA32609: Pin 3.2 x 60 mm
• M224OPA32509: Pin 3.2 x 50 mm
• M224OPA32409: Pin 3.2 x 40 mm
• M224OPA32309: Pin 3.2 x 30 mm
• M224OPA27709: Pin 2.7 x 70 mm
• M224OPA27609: Pin 2.7 x 60 mm
• M224OPA27509: Pin 2.7 x 50 mm
• M224OPA27409: Pin 2.7 x 40 mm
• M224OPA27309: Pin 2.7 x 30 mm
• M224OPA20709: Pin 2.0 x 70 mm
• M224OPA20609: Pin 2.0 x 60 mm
• M224OPA20509: Pin 2.0 x 50 mm
• M224OPA20409: Pin 2.0 x 40 mm
• M224OPA20309: Pin 2.0 x 30 mm
• M224OPA15709: Pin 1.5 x 70 mm
• M224OPA15609: Pin 1.5 x 60 mm
• M224OPA15509: Pin 1.5 x 50 mm
• M224OPA15409: Pin 1.5 x 40 mm
• M224OPA15309: Pin 1.5 x 30 mm
• 06438408004384: Pin kit 2.0 mm (3 pcs)
• 06438408004377: Pin Kit 2.0 mm (2 pcs)
• 06438408004360: Pin kit 2.0 mm (2+1 pcs)
• 06438408004353: Pin kit 1.5 mm (3 pcs)
• 06438408004346: Pin kit 1.5 mm (2 pcs)
• 06438408004339: Pin kit 1.5 mm (2+1 pcs)
• 06438408004322: Pin 3.2 x 70 mm
• 06438408004315: Pin 3.2 x 60 mm
• 06438408004308: Pin 3.2 x 50 mm
• 06438408004292: Pin 3.2 x 40 mm
• 06438408004285: Pin 3.2 x 30 mm
• 06438408004278: Pin 2.7 x 70 mm
• 06438408004261: Pin 2.7 x 60 mm
• 06438408004254: Pin 2.7 x 50 mm
• 06438408004247: Pin 2.7 x 40 mm
• 06438408004230: Pin 2.7 x 30 mm
• 06438408004223: Pin 2.0 x 70 mm
• 06438408004216: Pin 2.0 x 60 mm
• 06438408004209: Pin 2.0 x 50 mm
• 06438408004193: Pin 2.0 x 40 mm
• 06438408004186: Pin 2.0 x 30 mm
• 06438408004179: Pin 1.5 x 70 mm
• 06438408004162: Pin 1.5 x 60 mm
• 06438408004155: Pin 1.5 x 50 mm