MectaScrew C

GUDID 07630345703347

Composite Interference Screw 8x30 T25

Medacta International SA

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 07630345703347
• NIH Device Record Key: edb76578-2118-4866-bc96-0863c67d9fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaScrew C
• Version Model Number: 05.05.0106
• 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	07630345703347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203335

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: 2022-02-15
• Device Publish Date: 2022-02-07

On-Brand Devices [MectaScrew C]

• 07630345703422: Composite Interference Screw 12x35 T40
• 07630345703415: Composite Interference Screw 11x30 T40
• 07630345703408: Composite Interference Screw 10x30 T25
• 07630345703392: Composite Interference Screw 10x25 T25
• 07630345703385: Composite Interference Screw 10x20 T25
• 07630345703378: Composite Interference Screw 9x30 T25
• 07630345703361: Composite Interference Screw 9x25 T25
• 07630345703354: Composite Interference Screw 9x20 T25
• 07630345703347: Composite Interference Screw 8x30 T25
• 07630345703330: Composite Interference Screw 8x25 T25
• 07630345703323: Composite Interference Screw 8x20 T25
• 07630345703316: Composite Interference Screw 8x15 T25
• 07630345703309: Composite Interference Screw 7x30 T25
• 07630345703293: Composite Interference Screw 7x25 T25
• 07630345703286: Composite Interference Screw 7x20 T25
• 07630345703279: Composite Interference Screw 7x15 T25
• 07630345703262: Composite Interference Screw 6x25 T20
• 07630345703255: Composite Interference Screw 6x20 T20
• 07630345703248: Composite Interference Screw 6x15 T20