K-JAWS

GUDID 03613720192275

ANTERIOR CERVICAL STABILIZATION H: 20mm x L: 14mm

MEDICREA INTERNATIONAL

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 03613720192275
• NIH Device Record Key: 57332ad2-1032-469b-b9e2-20a2252b5802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-JAWS
• Version Model Number: B10122014
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	03613720192275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133906

FDA Product Code

• PHQ: Anterior Staple As Supplemental Fixation For Fusion

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: 2021-11-23
• Device Publish Date: 2015-10-23

On-Brand Devices [K-JAWS]

• 03613720192282: ANTERIOR CERVICAL STABILIZATION H: 20mm x L: 17mm
• 03613720192275: ANTERIOR CERVICAL STABILIZATION H: 20mm x L: 14mm
• 03613720192268: ANTERIOR CERVICAL STABILIZATION H: 20mm x L: 12mm
• 03613720192251: ANTERIOR CERVICAL STABILIZATION H: 17.5mm x L: 17mm
• 03613720192244: ANTERIOR CERVICAL STABILIZATION H: 17.5mm x L: 14mm
• 03613720192237: ANTERIOR CERVICAL STABILIZATION H: 17.5mm x L: 12mm
• 03613720192220: ANTERIOR CERVICAL STABILIZATION H: 15mm x L: 17mm
• 03613720192213: ANTERIOR CERVICAL STABILIZATION H: 15mm x L: 14mm
• 03613720192206: ANTERIOR CERVICAL STABILIZATION H: 15mm x L: 12mm