Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orbbo Surgical, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163265 | Kepler II | Orbbo Surgical, LLC | 2017-04-07 | 137 | 0 |
| K163602 | Kepler I Cervical Plate System | Orbbo Surgical, LLC | 2017-02-16 | 57 | 0 |
| K163566 | Hubble I System | Orbbo Surgical, LLC | 2017-02-09 | 52 | 0 |
| K163180 | Hubble II | Orbbo Surgical, LLC | 2016-12-29 | 45 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda