Adaptix Interbody System with Titan nanoLOCK Surface Technology
FDA 510(k) K201267 · Medtronic Sofamor Danek
510(k) numberK201267
Submission
- Device name
- Adaptix Interbody System with Titan nanoLOCK Surface Technology
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- May 12, 2020
- Decision date
- August 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…MAX · Traditional | 09/19/2017SE |
| K171031 | CRESCENT Spinal SystemMAX · Special | 07/06/2017SE |
| K171468 | FUSE Spinal SystemMAX · Special | 06/13/2017SE |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…NKB · Traditional | 05/11/2017SE |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM)…OUR · Traditional | 08/12/2016SE |
Questions and answers
When was Adaptix Interbody System with Titan nanoLOCK Surface Technology cleared by the FDA?
Adaptix Interbody System with Titan nanoLOCK Surface Technology (K201267) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 106 days after the submission was received.
What is the product code of K201267?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.