NuVasive AttraX Scaffold
FDA 510(k) K172497 · Nu Vasive, Incorporated
510(k) numberK172497
Submission
- Device name
- NuVasive AttraX Scaffold
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- August 18, 2017
- Decision date
- November 24, 2017
- 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 |
|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special | 07/11/2023SE |
| K230894 | NuVasive Modulus ALIF SystemOVD · Traditional | 06/16/2023SE |
| K230989 | Rod Registration FrameOLO · Special | 05/05/2023SE |
| K223181 | NuVasive Reline SystemNKB · Traditional | 01/11/2023SE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional | 10/21/2022SE |
| K221388 | NuVasive Reline Cervical SystemNKG · Traditional | 09/09/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | 06/21/2022SE |
| K213654 | NuVasive Reline Cervical SystemNKG · Traditional | 02/23/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | 12/23/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | 11/03/2021SE |
Questions and answers
When was NuVasive AttraX Scaffold cleared by the FDA?
NuVasive AttraX Scaffold (K172497) received a 510(k) decision of Substantially Equivalent on November 24, 2017, 98 days after the submission was received.
What is the product code of K172497?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.