Kepler II— 510(k) K163265

Name: FDA 510(k) clearance K163265
Creator: U.S. Food and Drug Administration
Published: 2017-04-07

Substantially Equivalent

Orbbo Surgical, LLC

FDA 510(k) clearance K163265 for Kepler II, Substantially Equivalent on 2017-04-07. Applicant: Orbbo Surgical, LLC. Device class: 2.

Clearance details

Applicant: Orbbo Surgical, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2016-11-21
Decision date: 2017-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

view all

K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Orbbo Surgical, LLC

view all

K163602 — Kepler I Cervical Plate System2017-02-16
K163566 — Hubble I System2017-02-09
K163180 — Hubble II2016-12-29

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.