MectaScrew PEEK

GUDID 07630040723466

Interference Screw 8x25 T25

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 07630040723466
• NIH Device Record Key: 9782e267-e2be-47b2-912f-b420e5fc69b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaScrew PEEK
• Version Model Number: 05.05.0012
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	07630040723466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190892

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-07-25

On-Brand Devices [MectaScrew PEEK]

• 07630040723558: Interference Screw 11x35 T40
• 07630040723541: Interference Screw 11x30 T40
• 07630040723534: Interference Screw 10x30 T25
• 07630040723527: Interference Screw 10x25 T25
• 07630040723510: Interference Screw 10x20 T25
• 07630040723503: Interference Screw 9x30 T25
• 07630040723497: Interference Screw 9x25 T25
• 07630040723480: Interference Screw 9x20 T25
• 07630040723473: Interference Screw 8x30 T25
• 07630040723466: Interference Screw 8x25 T25
• 07630040723459: Interference Screw 8x20 T25
• 07630040723442: Interference Screw 8x15 T25
• 07630040723435: Interference Screw 7x30 T25
• 07630040723428: Interference Screw 7x25 T25
• 07630040723411: Interference Screw 7x20 T25
• 07630040723404: Interference Screw 7x15 T25
• 07630040723398: Interference Screw 6x25 T20
• 07630040723381: Interference Screw 6x20 T20
• 07630040723374: Interference Screw 6x15 T20