Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integrated Surgical Systems, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072629 | DIGIMATCH ROBODOC SURGICAL SYSTEM | Integrated Surgical Systems, Inc. | 2008-08-06 | 324 | 0 |
| K991081 | FRAMELESS NEUROMATE | Integrated Surgical Systems, Inc. | 1999-06-25 | 86 | 0 |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | 1997-01-17 | 332 | 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