Identity
- Trade Name
- Opus Mg Set - Mixing and Delivery System FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. FDA UDI
- Model / Reference
- AUX FDA UDI
- Description
- The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. FDA UDI
Identifiers
- Catalog Number
- 712000 FDA UDI
- Primary DI / UDI-DI
- B4477120000 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Bone graft delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
Yes
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: Bone graft delivery kit
Opus Mg Set - Mixing and Delivery System by Bone Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft delivery kit.
- SCP® — Zimmer Knee Creations, Inc. · Class I
- SCP® — Zimmer Knee Creations, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SCP® PF Foot & Ankle Kit — Zimmer Knee Creations, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SCP® — Zimmer Knee Creations, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bone Solutions, Inc.
Sources (1)
- FDA UDI c189583b-e961-4f76-85e3-6b312786b18a 35 fields · synced Jun 8, 2026