GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM— 510(k) K130913

Name: FDA 510(k) clearance K130913
Creator: U.S. Food and Drug Administration
Published: 2013-12-13

Substantially Equivalent

Genesys Spine

FDA 510(k) clearance K130913 for GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM, Substantially Equivalent on 2013-12-13. Applicant: Genesys Spine. Device class: 2.

Clearance details

Applicant: Genesys Spine
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-04-02
Decision date: 2013-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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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 Genesys Spine

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K252322 — SIros-X System2025-10-22
K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System2025-02-07
K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation2024-03-29
K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System2023-12-13
K220096 — Genesys Spine 3DP Lumbar Interbody System2022-03-09

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.