Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Core Essence Orthopaedics, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES ( | Core Essence Orthopaedics, LLC | 2008-12-24 | 254 | 0 |
| K071477 | REVERTO 55 AND 37 SHAPE MEMORY STAPLES | Core Essence Orthopaedics, LLC | 2007-08-15 | 78 | 0 |
| K071520 | RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X | Core Essence Orthopaedics, LLC | 2007-08-10 | 67 | 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