Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
FDA 510(k) K000515 · Interpore Cross Intl.
510(k) numberK000515
Submission
- Device name
- Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- February 16, 2000
- Decision date
- September 15, 2000
- 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 |
| K031399 | Intergro DBMMQV · Traditional | 02/18/2005SE |
| 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 |
Questions and answers
When was Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, cleared by the FDA?
Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, (K000515) received a 510(k) decision of Substantially Equivalent on September 15, 2000, 212 days after the submission was received.
What is the product code of K000515?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.