Identity
- Trade Name
- M-ARS ACL: Anatomic Ribbon Surgery System FDA UDI
- Generic Name
- Ligament bone anchor FDA UDI
- Device Name
- Tibial Pull Suture Plate (PSP) FDA UDI
- Model / Reference
- 05.05.0001 FDA UDI
- Description
- Tibial Pull Suture Plate (PSP) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630040715744 FDA UDI
- 510(k) Number
- K171640 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Ligament bone anchor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Category: Ligament bone anchor
M-ARS ACL: Anatomic Ribbon Surgery System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ligament bone anchor.
- EZLOC — Biomet Sports Medicine · Class II
- MINI BONE MULCH — Biomet Sports Medicine · Class II
- EZLOC™ — Biomet Orthopedics, Inc. · Class II
- JUGGERKNOT — Biomet Orthopedics, Inc. · Class II
- TITANIUM INTERFERENCE SCREW — Biomet Sports Medicine · Class II
- AXL CROSSPIN — Biomet Sports Medicine · Class II
- Corifix Ligament Anchor Screw — CORIN LTD · Class II
- Corifix Ligament Anchor Screw — CORIN LTD · Class II
Cleared under the same submission
K171640 also covers:
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
- Medacta International
Sources (1)
- FDA UDI 5efc6bb8-3f01-4cd2-859e-bcb584ab2cb1 34 fields · synced May 30, 2026