Identity
- Trade Name
- Actifuse Flow FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size FDA UDI
- Model / Reference
- 506005078076 FDA UDI
- Description
- Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size FDA UDI
Identifiers
- Catalog Number
- 506005078076 FDA UDI
- Primary DI / UDI-DI
- 05060050780760 FDA UDI
- 510(k) Number
- K181306 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial 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
Dimensions & Sizes
- Size
- Total Volume — 1.5 Milliliter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Actifuse Flow by Apatech Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181306 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
- Apatech Ltd
Sources (1)
- FDA UDI ac15aa0a-fcdc-435a-a6c2-5d790efe05a2 38 fields · synced May 30, 2026