Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C.B.S. Biotechnics, 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) |
|---|---|---|---|---|---|
| K834364 | CRYSTALLINE BONE SCREW ENDO-OSSEOUS | C.B.S. Biotechnics, Inc. | 1984-03-06 | 131 | 0 |
| K834361 | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. | 1984-03-05 | 130 | 0 |
| K834363 | ENDIX RADICULAR BIOCERAMIC PIN | C.B.S. Biotechnics, Inc. | 1984-02-27 | 123 | 0 |
| K834366 | SURGICAL INSTRUMENTS & ACCESSORIES | C.B.S. Biotechnics, Inc. | 1984-02-27 | 123 | 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