EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages— 510(k) K170503

Name: FDA 510(k) clearance K170503
Creator: U.S. Food and Drug Administration
Published: 2017-07-11

Substantially Equivalent

Eit Emerging Implant Technologies GmbH

FDA 510(k) clearance K170503 for EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Substantially Equivalent on 2017-07-11. Applicant: Eit Emerging Implant Technologies GmbH. Device class: 2.

Clearance details

Applicant: Eit Emerging Implant Technologies GmbH
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-02-21
Decision date: 2017-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wurmlingen, DE

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

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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 K170503

K-number listed on FDA's recall record

Z-1323-2022 — EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060LClass II·Ongoing·DePuy Spine, Inc.·20220520
Z-1324-2022 — EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070SClass II·Ongoing·DePuy Spine, Inc.·20220520

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170503.

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