Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R. Thomas Grotz, M.D., Inc. — 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) |
|---|---|---|---|---|---|
| K984200 | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 | R. Thomas Grotz, M.D., Inc. | 1999-01-21 | 58 | 0 |
| K973031 | STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSER | R. Thomas Grotz, M.D., Inc. | 1997-11-03 | 81 | 0 |
| K965111 | STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, A | R. Thomas Grotz, M.D., Inc. | 1997-02-18 | 60 | 0 |
| K964927 | STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSE | R. Thomas Grotz, M.D., Inc. | 1997-02-07 | 60 | 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