Identity
- Trade Name
- OsteoXcell BA FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box. FDA UDI
- Model / Reference
- OSBA-010M FDA UDI
- Description
- Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box. FDA UDI
Identifiers
- Catalog Number
- OSBA-010M FDA UDI
- Primary DI / UDI-DI
- 05060548020279 FDA UDI
- 510(k) Number
- K202639 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
Yes
FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
OsteoXcell BA by Biostone, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202639 also covers:
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
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
- Biostone, Ltd.
Sources (1)
- FDA UDI 452bb4b2-f86c-45ea-991a-b711ea80149b 35 fields · synced May 30, 2026