Genesys Spine Binary Lumbar Plate System— 510(k) K173885

Clearance details

Applicant

Genesys Spine

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2017-12-21

Decision date

2018-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

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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

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

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 →