Identity
- Trade Name
- Accell Evo3 Putty FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- Accell Evo3 Putty, 10cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package. FDA UDI
- Model / Reference
- 02-5000-100 FDA UDI
- Description
- Accell Evo3 Putty, 10cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package. FDA UDI
Identifiers
- Catalog Number
- 02-5000-100 FDA UDI
- Primary DI / UDI-DI
- 10889981055417 FDA UDI
- FDA Product Code
- MQV FDA UDIMBP 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 Evo3 Putty is a sterile, implantable device designed to fill bony voids or gaps caused by trauma or surgery. Made from human demineralized bone matrix (DBM), it combines with carrier compounds to stimulate new bone growth and may be used in maxillofacial and mandibular bone.
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 TBM — 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
K103742 also covers:
- Accell Evo3 Putty — ISOTIS ORTHOBIOLOGICS, INC
- Accell Evo3 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC
- Trel X-Press 300 — Integra Lifesciences Corp.
- Trel X-Press 300 — Integra Lifesciences Corp.
- Trel X-Press 300 — Integra Lifesciences Corp.
- Accell Evo3 Putty — SeaSpine Orthopedics Corporation
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 e57e8a5c-6d72-4056-9722-0458d54f0d0d 38 fields · synced Jul 18, 2026