ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium— 510(k) K172199

Name: FDA 510(k) clearance K172199
Creator: U.S. Food and Drug Administration
Published: 2017-09-19

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K172199 for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, Substantially Equivalent on 2017-09-19. Applicant: Medtronic Sofamor Danek. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-07-21
Decision date: 2017-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

view all

K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Medtronic Sofamor Danek

view all

K212428 — Centerpiece Plate Fixation System2021-12-13
K201267 — Adaptix Interbody System with Titan nanoLOCK Surface Technology2020-08-26
K173125 — T2 STRATOSPHERE Expandable Corpectomy System2017-12-20
K171031 — CRESCENT Spinal System2017-07-06
K171468 — FUSE Spinal System2017-06-13

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.