Identity
- Trade Name
- MENIX DUO FDA UDI
- Generic Name
- Meniscus suture anchor FDA UDI
- Device Name
- MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture. FDA UDI
- Model / Reference
- Meniscal suture system, 2 anchors FDA UDI
- Description
- MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture. FDA UDI
Identifiers
- Catalog Number
- MEN0201901 FDA UDI
- Primary DI / UDI-DI
- 03760304680526 FDA UDI
- 510(k) Number
- K223122 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Meniscus suture anchor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Meniscus suture anchor
Menix Duo by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Meniscus suture anchor.
- Meniscus Suture - OUT IN — GM DOS REIS INDUSTRIA E COMERCIO LTDA · Class I
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Down — HEALTHIUM MEDTECH LIMITED · Class II
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Left — HEALTHIUM MEDTECH LIMITED · Class II
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-UP — HEALTHIUM MEDTECH LIMITED · Class II
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right — HEALTHIUM MEDTECH LIMITED · Class II
- MENIX — S.B.M · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- S.b.m
Sources (1)
- FDA UDI 34f262dd-1c13-41c8-b880-918e29ae09b0 35 fields · synced May 30, 2026