Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gpc Medical Limited · 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) |
|---|---|---|---|---|---|
| K203811 | GPC Intraheal Intramedullary Nailing System | Gpc Medical Limited | 2022-02-10 | 409 | 0 |
| K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Ra | Gpc Medical Limited | 2022-01-07 | 347 | 0 |
| K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal Syste | Gpc Medical Limited | 2017-03-31 | 147 | 0 |
| K143245 | GPC Intramedullary Nailing Systems | Gpc Medical Limited | 2015-09-30 | 322 | 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