Anulex Technologies, Inc.: FDA clearances and approvals
Anulex Technologies, Inc. has 12 FDA 510(k) clearances (first 2005, latest 2012), across 4 product codes in 3 review panels. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 189 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 4 | 4 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
Review panels
- General and Plastic Surgery (5)
- Neurology (4)
- Orthopedic (3)
Most recent Anulex Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121356 | MICRO/MINI N-PK(H) BONE ANCHOR | MBI | 2012-11-09 | 189 |
| K121354 | MICRO/MINI N-PK(F) BONE ANCHOR | MBI | 2012-11-09 | 189 |
| K113805 | FIXATE TISSUE BAND | GZB | 2012-02-23 | 62 |
| K113400 | FIXATE TISSUE BAND | GZB | 2011-12-16 | 29 |
| K112849 | FIXATE TISSUE BAND | GZB | 2011-10-27 | 28 |
| K111462 | FIXATE TISSUE BAND | GZB | 2011-09-08 | 105 |
| K100572 | VERSACLOSE, MODEL VC-200-01 | GAT | 2010-03-17 | 16 |
| K091432 | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 | GAT | 2009-06-12 | 29 |
| K082729 | RIMCLOSE BONE ANCHOR | MBI | 2008-12-19 | 92 |
| K062307 | XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS | GAT | 2006-09-01 | 24 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anulex Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Anulex Technologies, Inc. have?
Anulex Technologies, Inc. has 12 FDA 510(k) clearances (first 2005, latest 2012), across 4 product codes in 3 review panels.
How long does FDA take to clear Anulex Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Anulex Technologies, Inc.'s cleared 510(k)s is 55 days.
What devices does Anulex Technologies, Inc. make?
Its most frequent FDA product codes are GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 4); GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 4); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3).
Has Anulex Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Anulex Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 12 Anulex Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAT, Anulex Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.