InterGro DBM Paste DBM001
InterGro DBM Paste DBM001 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K082793 on 2 Apr 2009 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00888480585121), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00888480585121 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082793 | Date2 Apr 2009 | StatusActive |
Official records
- AccessGUDID record 00888480585121
- FDA 510(k) database K082793
Across registries
- FDA 510(k) K082793 decided 2 Apr 2009 Active
- FDA GUDID UDI-DI 00888480585121 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K082793
- Listed FDA GUDID 00888480585121
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- InterGro DBM Paste
- Generic name
- Human-derived demineralized bone matrix implant
- Model / Ref / Catalog
- DBM001
- Primary DI / UDI-DI
- 00888480585121
- 510(k) Number
- FDA product code
- MBP, MQV, GXP
- GMDN term
- Human-derived demineralized bone matrix implant
- Device class
- Class II
- Regulation number
- 888.3045, 882.5300
- GUDID distribution status
- In Commercial Distribution
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- CAP PLUS, EQUIVABONE, CAP/DBM by Etex Corp.
- GRAFTON DBM by Osteotech, Inc.
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