MENIX DUO MEN0201901

GUDID 03760304680526

MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.

S.B.M

Meniscus suture anchor
Primary Device ID03760304680526
NIH Device Record Key34f262dd-1c13-41c8-b880-918e29ae09b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENIX DUO
Version Model NumberMeniscal suture system, 2 anchors
Catalog NumberMEN0201901
Company DUNS772462123
Company NameS.B.M
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760304680526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

Devices Manufactured by S.B.M

03760304681738 - LIGAFIX / PULLUP2025-12-19
03760304681745 - LIGAFIX2025-12-19
03760304681752 - LIGAFIX2025-12-19
03760304681776 - PULLUP2025-12-19
03760304681592 - PULLUP2025-12-18 The Reusable suture retriever pin is intended to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruct
03760304681608 - PULLUP2025-12-18 The Reusable suture retriever pin is intended to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruct
03760304681714 - PULLUP2025-11-28
03760304681721 - LIGAFIX / PULLUP2025-11-28
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