MSP Metatarsal Shortening Plate Locking Screw

GUDID 00817701020301

12mm Locking Screw

NEXTREMITY SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00817701020301
• NIH Device Record Key: d0c6876c-4a7c-4757-861e-b6b313c3701f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSP Metatarsal Shortening Plate Locking Screw
• Version Model Number: MS-2412L
• Company DUNS: 060783407
• Company Name: NEXTREMITY SOLUTIONS, 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: 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	00817701020301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140724

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [MSP Metatarsal Shortening Plate Locking Screw]

• 00817701020332: 18mm Locking Screw
• 00817701020325: 16mm Locking Screw
• 00817701020318: 14mm Locking Screw
• 00817701020301: 12mm Locking Screw
• 00817701020295: 10mm Locking Screw
• 00817701020288: 8mm Locking Screw