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Mixing and Delivery System
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K192674
Identity
- Trade Name
- 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
- Beat Mat Pak 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
- 712001 FDA UDI
- Primary DI / UDI-DI
- B4477120010 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone graft delivery kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mixing and Delivery System by Bone Solutions, Inc. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192674 | Class I | Active |
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Manufacturer
- Manufacturer
- Bone Solutions, Inc.
Sources (2)
- FDA UDI 1d7506be-0c0e-44f7-b780-ad4910215d3d 60 fields · synced Jun 18, 2026
- FDA 510(k) K192674 1 fields · synced Jun 5, 2026