Fibergraft BG Putty Bone Graft Substitute
FDA 510(k) K143533 · Prosidyan, Inc.
510(k) numberK143533
Submission
- Device name
- Fibergraft BG Putty Bone Graft Substitute
- Applicant
- Prosidyan, Inc.
Warren, NJ, US - Received
- December 12, 2014
- Decision date
- March 25, 2015
- 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 |
|---|---|---|
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | 10/22/2025SE |
| K251648 | GPS Advanced; GPS Advanced CannulaFMF · Special | 06/24/2025SE |
| K241426 | GPS Advanced; 5 cc GPS Advanced CannulaFMF · Traditional | 07/10/2024SE |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteMQV · Traditional | 08/23/2022SE |
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteMQV · Traditional | 12/20/2018SE |
| K180080 | FIBERGRAFT BG Matrix Bone Graft SubstituteMQV · Traditional | 04/06/2018SE |
| K171284 | FIBERGRAFT BG Matrix Bone Graft SubstituteMQV · Traditional | 06/30/2017SE |
| K170306 | FIBERGRAFT BG Putty Bone Graft SubstituteMQV · Traditional | 05/24/2017SE |
| K151154 | FIBERGRAFT BG MorselsMQV · Traditional | 11/10/2015SE |
| K141956 | Fibergraft BG MorselsMQV · Special | 08/13/2014SE |
Questions and answers
When was Fibergraft BG Putty Bone Graft Substitute cleared by the FDA?
Fibergraft BG Putty Bone Graft Substitute (K143533) received a 510(k) decision of Substantially Equivalent on March 25, 2015, 103 days after the submission was received.
What is the product code of K143533?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.