Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anulex Technologies, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
189 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121356 | MICRO/MINI N-PK(H) BONE ANCHOR | Anulex Technologies, Inc. | 2012-11-09 | 189 | 0 |
| K121354 | MICRO/MINI N-PK(F) BONE ANCHOR | Anulex Technologies, Inc. | 2012-11-09 | 189 | 0 |
| K113805 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2012-02-23 | 62 | 0 |
| K113400 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-12-16 | 29 | 0 |
| K112849 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-10-27 | 28 | 0 |
| K111462 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-09-08 | 105 | 0 |
| K100572 | VERSACLOSE, MODEL VC-200-01 | Anulex Technologies, Inc. | 2010-03-17 | 16 | 0 |
| K091432 | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 | Anulex Technologies, Inc. | 2009-06-12 | 29 | 0 |
| K082729 | RIMCLOSE BONE ANCHOR | Anulex Technologies, Inc. | 2008-12-19 | 92 | 0 |
| K062307 | XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS | Anulex Technologies, Inc. | 2006-09-01 | 24 | 0 |
| K061386 | ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB | Anulex Technologies, Inc. | 2006-07-05 | 48 | 0 |
| K050969 | INCLOSE SURGICAL MESH SYSTEM | Anulex Technologies, Inc. | 2005-08-18 | 122 | 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