Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Twin City Surgical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
93 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870767 | THE (CROM) TESTER | Twin City Surgical, Inc. | 1987-03-17 | 19 | 0 |
| K861632 | SIMS CHAIR | Twin City Surgical, Inc. | 1986-05-27 | 28 | 0 |
| K830585 | ANVIL RETRACTOR | Twin City Surgical, Inc. | 1983-05-27 | 93 | 0 |
| K820659 | A CALIPER | Twin City Surgical, Inc. | 1982-03-19 | 9 | 0 |
| K820660 | A HOOK DRIVER | Twin City Surgical, Inc. | 1982-03-19 | 9 | 0 |
| K813067 | SPINAL WRENCH | Twin City Surgical, Inc. | 1981-11-24 | 25 | 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