EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
FDA 510(k) K243609 · Etex Corporation
510(k) numberK243609
Submission
- Device name
- EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
- Applicant
- Etex Corporation
Braintree, MA, US - Received
- November 22, 2024
- Decision date
- December 18, 2024
- 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 |
|---|---|---|
| K182107 | CarriGen PFMQV · Special | 08/31/2018SE |
| K132868 | CarricellMQV · Traditional | 02/20/2015SE |
| K141245 | Etex Mixing and Delivery SystemFMF · Traditional | 07/09/2014SE |
| K100883 | CarrigenLYC · Traditional | 12/21/2010SE |
| K102812 | Gamma-Bsm; Beta-Bsm; EquivaboneLYC · Special | 12/03/2010SE |
| K101557 | Gamma-Bsm, Beta-Bsm, Equivabone, CarigenMQV · Special | 07/01/2010SE |
| K093447 | CarrigenMQV · Special | 02/18/2010SE |
| K091729 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneLYC · Traditional | 12/23/2009SE |
| K091607 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneMQV · Traditional | 11/02/2009SE |
| K090855 | Equivabone Osteoinductive Bone Graft SubstituteMQV · Traditional | 09/18/2009SE |
Questions and answers
When was EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) cleared by the FDA?
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (K243609) received a 510(k) decision of Substantially Equivalent on December 18, 2024, 26 days after the submission was received.
What is the product code of K243609?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.