Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Centerpulse Spine-Tech, 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) |
|---|---|---|---|---|---|
| K033679 | COPSIOS BONE VOID FILLER (BVF) | Centerpulse Spine-Tech, Inc. | 2004-07-07 | 226 | 0 |
| K031511 | DYNESYS SPINAL SYSTEM | Centerpulse Spine-Tech, Inc. | 2004-03-05 | 296 | 4 |
| K022615 | CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR | Centerpulse Spine-Tech, Inc. | 2002-10-29 | 83 | 0 |
| K022344 | TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM | Centerpulse Spine-Tech, Inc. | 2002-09-24 | 67 | 1 |
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