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SureMAX-SA

Model 1 · ADDITIVE IMPLANTS, LLC · DI 00817662026008

LYQ — Accessories, Fixation, Spinal Intervertebral Body · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01112022-05: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device0501
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0501
2025-0101
This device (reports/month)Average device in LYQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K211111 — cites (transitively): K151939 (d1), K083389 (d2), K113559 (d2), K131449 (d2), K150053 (d2), K091088 (d3) — cited as predicate by K222903, K223105, K230608

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — ADDITIVE IMPLANTS, LLC

Nothing in the loaded window.