NuVasive AttraX Scaffold
FDA 510(k) K240507 · Nuvasive, Inc.
510(k) numberK240507
Submission
- Device name
- NuVasive AttraX Scaffold
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- February 21, 2024
- Decision date
- March 20, 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 |
|---|---|---|
| K233706 | Bendini Cloud ApplicationOLO · Traditional | 08/02/2024SE |
| K223731 | NuVasive Modulus-C Interbody SystemODP · Special | 01/12/2023SE |
| K211757 | Simplify DiscQLQ · Traditional | 08/20/2021SE |
| K173117 | NuVasive® VersaTie SystemOWI · Traditional | 12/07/2017SE |
| K141665 | NuVasive CoRoent SystemMAX · Traditional | 03/13/2015SE |
| K142205 | NuVasive X-CORE(R) Expandable VBR SystemMQP · Traditional | 02/20/2015SE |
| K141968 | Nuvasive NVM5 SystemPDQ · Traditional | 11/14/2014SE |
| K140319 | Coroent Ti-C SystemMAX · Traditional | 10/09/2014SE |
| K140162 | Ap Expandable Xlif SystemMAX · Traditional | 07/02/2014SE |
| K140003 | Coroent Small Interbody SystemODP · Traditional | 04/03/2014SE |
Questions and answers
When was NuVasive AttraX Scaffold cleared by the FDA?
NuVasive AttraX Scaffold (K240507) received a 510(k) decision of Substantially Equivalent on March 20, 2024, 28 days after the submission was received.
What is the product code of K240507?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.