Identity
- Trade Name
- RegenaVate™ Formable DBM RT, 1cc FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- Formable DBM RT, 1cc FDA UDI
- Model / Reference
- ZR0201 FDA UDI
- Description
- Formable DBM RT, 1cc FDA UDI
Identifiers
- Catalog Number
- 005301Z FDA UDI
- Primary DI / UDI-DI
- 00854095006764 FDA UDI
- 510(k) Number
- K080418 FDA UDI
- FDA Product Code
- NUN FDA UDI
- GMDN Term
- Bone matrix implant, human-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
RegenaVate™ Formable DBM RT, 1cc by Rti Surgical, 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
K080418 also covers:
- RegenaVate™ Formable DBM RT, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM RT, 2cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM RT, 2cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc — Rti Surgical, Inc.
- Allo-3D-Plus — SALVIN DENTAL SPECIALTIES, LLC
- Allo-3D-Plus — SALVIN DENTAL SPECIALTIES, LLC
- Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLC
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
- Rti Surgical, Inc.
Sources (1)
- FDA UDI c8e3eff2-8d80-4647-b475-1562bb6924ca 36 fields · synced May 30, 2026