Bi-Ostetic Foam and Putty, Generos Foam and Putty
FDA 510(k) K092046 · Berkeley Advanced Biomaterials, Inc.
510(k) numberK092046
Submission
- Device name
- Bi-Ostetic Foam and Putty, Generos Foam and Putty
- Applicant
- Berkeley Advanced Biomaterials, Inc.
Berkeley, CA, US - Received
- July 6, 2009
- Decision date
- March 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | 08/27/2026SE |
| K170917 | Bi-Ostetic Bioactive Glass FoamMQV · Traditional | 10/30/2017SE |
| K113791 | B-Genin, R-GeninMQV · Traditional | 03/15/2012SE |
| K091912 | B-Genin and R-GeninMQV · Traditional | 06/23/2010SE |
| K053213 | Bi-Ostetic Foam, Cem-Ostetic Foam, Tri-Ostetic Foam, Generos FoamMQV · Traditional | 07/06/2006SE |
| K051914 | Generos 80, Generos 60MQV · Special | 11/03/2005SE |
| K051695 | Marrow Plus (M+)MQV · Traditional | 07/19/2005SE |
| K050666 | Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, Go-Xyz…MQV · Traditional | 04/11/2005SE |
| K042636 | BioplusMQV · Special | 12/14/2004SE |
| K041889 | Tri-OsteticMQV · Special | 08/19/2004SE |
Questions and answers
When was Bi-Ostetic Foam and Putty, Generos Foam and Putty cleared by the FDA?
Bi-Ostetic Foam and Putty, Generos Foam and Putty (K092046) received a 510(k) decision of Substantially Equivalent on March 24, 2010, 261 days after the submission was received.
What is the product code of K092046?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.