PIP Fix PFX-426

GUDID 00861994000243

External fixation system for dorsal fracture dislocations of the PIP joint.

Hand Biomechanics Lab Inc

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00861994000243
• NIH Device Record Key: d0d4c2e4-26cd-46e5-907d-85f94bb31699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIP Fix
• Version Model Number: PFX-426
• Catalog Number: PFX-426
• Company DUNS: 620754127
• Company Name: Hand Biomechanics Lab 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com
• Phone: 800-522-5778
• Email: info@handbiolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861994000243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181192

FDA Product Code

• JEC: Component, Traction, Invasive

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: 2019-03-11
• Device Publish Date: 2019-02-20

Devices Manufactured by Hand Biomechanics Lab Inc

• 00861994000281 - Disposable Blade Assembly: 2021-12-14 Endoscopic Carpal Tunnel Release Disposable Blade Assembly
• 00861994000243 - PIP Fix: 2019-03-11External fixation system for dorsal fracture dislocations of the PIP joint.
• 00861994000243 - PIP Fix: 2019-03-11 External fixation system for dorsal fracture dislocations of the PIP joint.
• 00861994000205 - Agee WristJack®: 2018-07-06 Fracture Reduction System. Fracture reduction and external fixation for treatment of distal radius fractures.
• 00861994000212 - Agee Digit Widget®: 2018-07-06 External fixation system for treatment of PIP joint flexion contractures.
• 00861994000229 - Agee TurnKey FCS®: 2018-07-06 External fixation system for acute dorsal fracture dislocations of the PIP joint.
• 00861994000236 - Agee WristJack® Remanufactured: 2018-07-06 Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fract