Identity
- Trade Name
- osteoSPAN FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- 6x6x40mm osteoSPAN Blocks FDA UDI
- Model / Reference
- 100-SLF FDA UDI
- Description
- 6x6x40mm osteoSPAN Blocks FDA UDI
Identifiers
- Catalog Number
- 100-SLF FDA UDI
- Primary DI / UDI-DI
- 00812593020606 FDA UDI
- 510(k) Number
- K093342 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft 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
- Length — 40 Millimeter FDA UDIHeight — 6 Millimeter FDA UDIWidth — 6 Millimeter FDA UDI
Category: Synthetic bone graft
osteoSPAN by Biogennix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic bone graft.
- Beta-bsm ® — Etex Corp. · Class II
- BIO2 TECHNOLOGIES — Bio2 Technologies, Inc. · Class II
- Bicera® Resorbable Bone Substitute — Wiltrom Co., Ltd. (Chutung) · Class II
- Montage Settable Bone Putty — ABYRX, INC. · Class II
- IngeniOS HA — curasan AG · Class II
- Osbone Dental — curasan AG · Class II
- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
- InQu — Isto Technologies, Inc. · Class II
Cleared under the same submission
K093342 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biogennix, LLC
Sources (1)
- FDA UDI b6db1f7f-095e-4269-9066-ff5c8fb63584 36 fields · synced May 30, 2026