Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pisharodi Surgicals, 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) |
|---|---|---|---|---|---|
| K070335 | SIMPLEX CERVICAL FIXATION SYSTEM | Pisharodi Surgicals, Inc. | 2007-04-16 | 70 | 0 |
| K033951 | RADIX CERVICAL PLATE | Pisharodi Surgicals, Inc. | 2004-07-01 | 192 | 0 |
| K024313 | MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW S | Pisharodi Surgicals, Inc. | 2003-08-29 | 248 | 0 |
| K014302 | UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM | Pisharodi Surgicals, Inc. | 2002-03-29 | 88 | 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