Identity
- Trade Name
- Accell TBM FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty. FDA UDI
- Model / Reference
- 02-4000-520 FDA UDI
- Description
- Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty. FDA UDI
Identifiers
- Catalog Number
- 02-4000-520 FDA UDI
- Primary DI / UDI-DI
- 10889981055646 FDA UDI
- 510(k) Number
- K061880 FDA UDI
- FDA Product Code
- MBP FDA UDIMQV FDA UDI
- GMDN Term
- Bone matrix implant, human-derived 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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, human-derived
Accell TBM by Isotis Orthobiologics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, human-derived.
- Vivex DBM Plus — Hans Biomed Corporation · Class II
- DBM Putty 10.0cc Jar — Xtant Medical Holdings, Inc. · Class II
- DBM Putty 10.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
- OsteoSelect (DBM) Putty 5.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
- InterGro DBM Paste — Biomet Orthopedics, Inc. · Class II
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Trel-X Putty — Integra Lifesciences Corp. · Class II
- Puros® — ZIMMER SPINE, INC. · Class II
Cleared under the same submission
K061880 also covers:
- Accell Evo3 Putty — ISOTIS ORTHOBIOLOGICS, INC
- Accell Evo3 Putty — ISOTIS ORTHOBIOLOGICS, INC
- Accell Evo3 Putty — ISOTIS ORTHOBIOLOGICS, INC
- Accell TBM — ISOTIS ORTHOBIOLOGICS, INC
- Accell TBM — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 100 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 100 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 100 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 100 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
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
- Isotis Orthobiologics, Inc
Sources (1)
- FDA UDI 42995f43-780d-45ee-9ae0-bd196195f77a 38 fields · synced Jun 8, 2026