MENIX MEN0201902

GUDID 03760304680533

MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.

S.B.M

Meniscus suture anchor

• Primary Device ID: 03760304680533
• NIH Device Record Key: 99f89312-a725-4687-bce5-1fab2ca6134d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENIX
• Version Model Number: Meniscal suture system, 1 anchor
• Catalog Number: MEN0201902
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: 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	03760304680533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223122

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2023-09-19
• Device Publish Date: 2023-09-11

On-Brand Devices [MENIX]

• 03760304680533: MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed
• 03760304680779: MENIX Arthroscopic scissors to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680762: MENIX rasp to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680755: MENIX 90 degree probe to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680748: MENIX Knot pusher to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680731: MENIX Twister to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680557: MENIX Suture cutter to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680540: MENIX Portal skid to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680816: Complete instrumentation set intended to be used for arthroscopic meniscus repair.