FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K Number: K172199
·
Decision Sep 19, 2017
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
154
Review Days
60
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Basic Information
- Device Name
- ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
- K Number
- K172199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek
- Date Received
- July 21, 2017
- Decision Date
- September 19, 2017
- Product Code
- MAX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Medtronic Sofamor Danek
| K Number | Device Name | ||
|---|---|---|---|
| K212428 | Centerpiece Plate Fixation System | Dec 13, 2021 | Substantially Equivalent |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Aug 26, 2020 | Substantially Equivalent |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | Dec 20, 2017 | Substantially Equivalent |
| K171031 | CRESCENT Spinal System | Jul 6, 2017 | Substantially Equivalent |
| K171468 | FUSE Spinal System | Jun 13, 2017 | Substantially Equivalent |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | May 11, 2017 | Substantially Equivalent |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | Aug 12, 2016 | Substantially Equivalent |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device | Jan 19, 2016 | Substantially Equivalent |
| K140276 | CD HORIZON SPINAL SYSTEM | Mar 13, 2014 | Substantially Equivalent |
| K123246 | CD HORIZON SPIRE Z SPINAL SYSTEM | Nov 16, 2012 | Unknown |