Identity
- Trade Name
- BoneMedik, 4~6mm, 5cc FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite. FDA UDI
- Model / Reference
- 9529 FDA UDI
- Description
- BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387895299 FDA UDI
- 510(k) Number
- K070897 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
- Not 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
No
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
Yes
FDA UDI
BoneMedik, 4~6mm, 5cc by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K070897 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
- Meta Biomed, Inc.
Sources (1)
- FDA UDI dc79bdf3-9fd5-477e-9238-324ee3419931 35 fields · synced May 31, 2026