Identity
- Trade Name
- SpineSmith Fusionary Graft Delivery System FDA UDI
- Generic Name
- Bone graft syringe, single-use FDA UDI
- Device Name
- BMA Kit with 30cc Syringes FDA UDI
- Model / Reference
- 0851-0030 FDA UDI
- Description
- BMA Kit with 30cc Syringes FDA UDI
Identifiers
- Catalog Number
- 0851-0030 FDA UDI
- Primary DI / UDI-DI
- 00817771027316 FDA UDI
- FDA Product Code
- FMF FDA UDILWE FDA UDI
- GMDN Term
- Bone graft syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 graft syringe, single-use
SpineSmith Fusionary Graft Delivery System by Celling Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone graft syringe, single-use.
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Cleared under the same submission
BK090047 also covers:
- SpineSmith Fusionary Graft Delivery System — Celling Biosciences
- SpineSmith Fusionary Graft Delivery System — Celling Biosciences
- SpineSmith Fusionary Graft Delivery System — Celling Biosciences
- SpineSmith Fusionary Graft Delivery System — Celling Biosciences
- SpineSmith Fusionary Graft Delivery System — Celling Biosciences
- SpineSmith Fusionary Graft Delivery System — Celling Biosciences
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Celling Biosciences
Sources (1)
- FDA UDI a6b260c5-b3ef-4227-afc1-5aba7ad7735b 36 fields · synced May 30, 2026