FLXfit— 510(k) K171519

Name: FDA 510(k) clearance K171519
Creator: U.S. Food and Drug Administration
Published: 2017-09-15

Substantially Equivalent

Expanding Orthopedics, Inc.

FDA 510(k) clearance K171519 for FLXfit, Substantially Equivalent on 2017-09-15. Applicant: Expanding Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Expanding Orthopedics, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-05-24
Decision date: 2017-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Expanding Orthopedics, Inc.

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K133813 — FLXFIT INTERVERTEBRAL BODY FUSION DEVICE2014-07-15
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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 →

Recalls naming K171519

K-number listed on FDA's recall record

Z-0954-2023 — CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208Class II·Terminated·CoreLink LLC·20221020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171519.

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