StabilizOrtho

GUDID B650SFX830800

SimpliFix Cannulated Screw 8.3mm x 80mm

Stabiliz Orthopaedics, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: B650SFX830800
• NIH Device Record Key: 2bb0a14d-c704-4459-8b07-27f4f169c1d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabilizOrtho
• Version Model Number: SFX83080
• Company DUNS: 832740091
• Company Name: Stabiliz Orthopaedics, Inc.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B650SFX830800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230053

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [StabilizOrtho]

• B650SFX831200: SimpliFix Cannulated Screw 8.3mm x 120mm
• B650SFX831150: SimpliFix Cannulated Screw 8.3mm x 115mm
• B650SFX831100: SimpliFix Cannulated Screw 8.3mm x 110mm
• B650SFX831050: SimpliFix Cannulated Screw 8.3mm x 105mm
• B650SFX831000: SimpliFix Cannulated Screw 8.3mm x 100mm
• B650SFX830950: SimpliFix Cannulated Screw 8.3mm x 95mm
• B650SFX830900: SimpliFix Cannulated Screw 8.3mm x 90mm
• B650SFX830850: SimpliFix Cannulated Screw 8.3mm x 85mm
• B650SFX830800: SimpliFix Cannulated Screw 8.3mm x 80mm
• B650SFX830750: SimpliFix Cannulated Screw 8.3mm x 75mm
• B650SFX830700: SimpliFix Cannulated Screw 8.3mm x 70mm
• B650SCS370900: SimpliFix Cross Screw 3.7mm x 90mm
• B650SCS370850: SimpliFix Cross Screw 3.7mm x 85mm
• B650SCS370800: SimpliFix Cross Screw 3.7mm x 80mm
• B650SCS370750: SimpliFix Cross Screw 3.7mm x 75mm
• B650SCS370700: SimpliFix Cross Screw 3.7mm x 70mm
• B650SCS370650: SimpliFix Cross Screw 3.7mm x 65mm
• B650SCS370600: SimpliFix Cross Screw 3.7mm x 60mm
• B650SCS370550: SimpliFix Cross Screw 3.7mm x 55mm
• B650SCS370500: SimpliFix Cross Screw 3.7mm x 50mm
• B650SCS370450: SimpliFix Cross Screw 3.7mm x 45mm