Intergro DBM
FDA 510(k) K031399 · Interpore Cross Intl.
510(k) numberK031399
Submission
- Device name
- Intergro DBM
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- May 5, 2003
- Decision date
- February 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K050861 | PEEK CasMQP · Special | 05/27/2005SE |
| K041407 | Titanium Mesh ImplantMQP · Traditional | 12/29/2004SE |
| K043229 | Modification to Altius Oct SystemKWP · Special | 12/21/2004SE |
| K042798 | C-Tek C-Trun Anterior Cervical Plate SystemKWQ · Special | 11/04/2004SE |
| K040928 | Expandable PEEK VBR ImplantMQP · Traditional | 08/27/2004SE |
| K041794 | C-Tek C-Thru Anterior Cervical Plate SystemKWQ · Special | 07/19/2004SE |
| K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatKWP · Special | 07/01/2004SE |
| K033961 | Altius Oct SystemKWP · Special | 04/14/2004SE |
| K040168 | Modification to Geo StructureMQP · Special | 04/08/2004SE |
| K031772 | Ti Fenestrated PlateKWP · Abbreviated | 09/05/2003SE |
Questions and answers
When was Intergro DBM cleared by the FDA?
Intergro DBM (K031399) received a 510(k) decision of Substantially Equivalent on February 18, 2005, 655 days after the submission was received.
What is the product code of K031399?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.