Identity
- Trade Name
- Trel-X Putty FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- Trel-X™Putty, 10cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package. FDA UDI
- Model / Reference
- TXP10 FDA UDI
- Description
- Trel-X™Putty, 10cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package. FDA UDI
Identifiers
- Catalog Number
- TXP10 FDA UDI
- Primary DI / UDI-DI
- 10381780112488 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, human-derived
Trel-X Putty by Integra Lifesciences Corp. — 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
- Puros® — ZIMMER SPINE, INC. · Class II
- BioSet® — Rti Surgical, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 3112385b-0b1e-4627-840c-f1c768325740 38 fields · synced May 31, 2026