Identity
- Trade Name
- OSTEOMATRIX+ FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. FDA UDI
- Model / Reference
- 9cc FDA UDI
- Description
- OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. FDA UDI
Identifiers
- Catalog Number
- OMP-09 FDA UDI
- Primary DI / UDI-DI
- 00816986020112 FDA UDI
- 510(k) Number
- K160446 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 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
No
FDA UDI
Category: Synthetic bone graft
Osteomatrix+ by Bioventus Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160446 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
- Bioventus Llc
Sources (1)
- FDA UDI 81ed12b2-cb6d-4cb9-abcd-0864ab40893f 37 fields · synced May 30, 2026