Identity
- Trade Name
- Dynagraft II Putty FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- DynaGraft II Putty, 1cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency. FDA UDI
- Model / Reference
- 02-2010-010 FDA UDI
- Description
- DynaGraft II Putty, 1cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency. FDA UDI
Identifiers
- Catalog Number
- 02-2010-010 FDA UDI
- Primary DI / UDI-DI
- 10889981055547 FDA UDI
- 510(k) Number
- K040419 FDA UDI
- FDA Product Code
- MQV 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
Dynagraft II Putty 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
K040419 also covers:
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Arthrex — ISOTIS ORTHOBIOLOGICS, INC
- Dynagraft II Gel — ISOTIS ORTHOBIOLOGICS, INC
- Dynagraft II Gel — ISOTIS ORTHOBIOLOGICS, INC
- Dynagraft II Gel — ISOTIS ORTHOBIOLOGICS, INC
- Dynagraft II Gel — ISOTIS ORTHOBIOLOGICS, INC
- Dynagraft II 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 f7a916cc-0961-41f9-ab5e-ba91b5f9afd1 38 fields · synced Jun 6, 2026