ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
FDA 510(k) K172199 · Medtronic Sofamor Danek
510(k) numberK172199
Submission
- Device name
- ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- July 21, 2017
- Decision date
- September 19, 2017
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone GraftMQV · Traditional | 06/12/2025SE |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMQV · Traditional | 01/17/2025SE |
| K230716 | Robotic Graft Delivery InstrumentsOLO · Traditional | 07/18/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | 12/13/2021SE |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMAX · Traditional | 08/26/2020SE |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Traditional | 12/20/2017SE |
| 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 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium cleared by the FDA?
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium (K172199) received a 510(k) decision of Substantially Equivalent on September 19, 2017, 60 days after the submission was received.
What is the product code of K172199?
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.