Inion FreedomPin™ OPK-20K3

GUDID M224OPK20K39

Pin kit 2.0 mm (3 pcs)

Inion Oy

Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable

• Primary Device ID: M224OPK20K39
• NIH Device Record Key: 57d7356e-2b9f-4d5f-bcb7-35ce3fdd528c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion FreedomPin™
• Version Model Number: 1
• Catalog Number: OPK-20K3
• 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	06438408004384 [Secondary]
HIBCC	M224OPK20K39 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-02-07

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