GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM— 510(k) K130317

Name: FDA 510(k) clearance K130317
Creator: U.S. Food and Drug Administration
Published: 2013-12-11

Substantially Equivalent

Genesys Spine

FDA 510(k) clearance K130317 for GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM, Substantially Equivalent on 2013-12-11. Applicant: Genesys Spine. Device class: 2.

Clearance details

Applicant: Genesys Spine
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-02-08
Decision date: 2013-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Genesys Spine

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K252322 — SIros-X System2025-10-22
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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 ODP

product code ODP

Injury: 310
Total: 310

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.