OsteoFlo® HydroPutty
FDA 510(k) K231716 · SurGenTec, LLC
510(k) numberK231716
Submission
- Device name
- OsteoFlo® HydroPutty
- Applicant
- SurGenTec, LLC
Boca Raton, FL, US - Received
- June 13, 2023
- Decision date
- October 2, 2023
- 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 |
|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | 08/26/2026SE |
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | 08/24/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | 07/24/2026SE |
| K261209 | Ion-LMRW · Traditional | 06/11/2026SE |
| K260329 | Ion-C Navigation InstrumentsOLO · Traditional | 05/22/2026SE |
| K253604 | TiLink-L Navigation InstrumentsOLO · Traditional | 03/20/2026SE |
| K251714 | Ion-CMRW · Traditional | 01/16/2026SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | 07/02/2025SE |
| K243949 | OsteoFlo HydroFiberMQV · Traditional | 05/28/2025SE |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | 04/24/2025SE |
Questions and answers
When was OsteoFlo® HydroPutty cleared by the FDA?
OsteoFlo® HydroPutty (K231716) received a 510(k) decision of Substantially Equivalent on October 2, 2023, 111 days after the submission was received.
What is the product code of K231716?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.