InFill® Interbody Fusion Device— 510(k) K172349

Name: FDA 510(k) clearance K172349
Creator: U.S. Food and Drug Administration
Published: 2017-12-14

Substantially Equivalent

Pinnacle Spine Group, LLC

FDA 510(k) clearance K172349 for InFill® Interbody Fusion Device, Substantially Equivalent on 2017-12-14. Applicant: Pinnacle Spine Group, LLC. Device class: 2.

Clearance details

Applicant: Pinnacle Spine Group, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-08-03
Decision date: 2017-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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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 Pinnacle Spine Group, LLC

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K152259 — InFill Interbody Fusion Device2015-11-19
K151184 — InFill Interbody Fusion Devices2015-07-14
K150206 — InFill Interbody Fusion Devices2015-04-03
K143488 — InFill Graft Delivery System2014-12-17
K140066 — INFILL CERVICAL2014-05-05

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.