Identity
- Trade Name
- MacroFORM Bioactive Packable Graft 5.0cc FDA UDI
- Generic Name
- Bone matrix implant, composite FDA UDI
- Device Name
- Synthetic bone void filler for orthopedic applications FDA UDI
- Model / Reference
- NB0399 FDA UDI
- Description
- Synthetic bone void filler for orthopedic applications FDA UDI
Identifiers
- Catalog Number
- NB0399 FDA UDI
- Primary DI / UDI-DI
- 00813909010816 FDA UDI
- 510(k) Number
- K140946 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, composite 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: Bone matrix implant, composite
MacroFORM Bioactive Packable Graft 5.0cc by NovaBone Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, composite.
- nanOss Loaded Advanced Bone Graft Substitute Kit — Xtant Medical Holdings, Inc. · Class II
- CopiOs® Bone Void Filler Paste — DSM BIOMEDICAL, INC. · Class II
- Vitoss — Stryker Corp. · Class II
- STRATOFUSE Strip — Berkeley Advanced Biomaterials · Class II
- OptiFuse Bi-Ostetic Foam Strip — Berkeley Advanced Biomaterials · Class II
- AlexiFuse Synthetic Foam Strip — Berkeley Advanced Biomaterials · Class II
- BiSyntek Putty — Berkeley Advanced Biomaterials · Class II
- nanOss 3D Plus Advanced Bone Graft Substitute — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K140946 also covers:
- MacroFORM Bioactive Packable Graft 10.0cc — NovaBone Products, LLC
- MacroFORM Bioactive Packable Graft 15.0cc — NovaBone Products, LLC
- MacroFORM Bioactive Packable Graft 2 x 10.0cc — NovaBone Products, LLC
- MacroFORM Bioactive Packable Graft 5.0cc — NovaBone Products, LLC
- MacroFORM Composite 10.0cc — NovaBone Products, LLC
- MacroFORM Composite 2.5cc — NovaBone Products, LLC
- MacroFORM Composite 2.5cc — NovaBone Products, LLC
- MacroFORM Composite 5.0cc — NovaBone Products, LLC
- MacroFORM Composite 5.0cc — NovaBone Products, LLC
- MacroFORM Composite 6.0cc — NovaBone Products, LLC
- MacroFORM Composite Bullet 1.0cc — NovaBone Products, LLC
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
- NovaBone Products, LLC
Sources (1)
- FDA UDI 4ef4afd2-fa87-412a-b380-464bda9e97bc 37 fields · synced Jun 9, 2026