Advanced Spine Fixation Systems, Inc.: FDA clearances and approvals
Advanced Spine Fixation Systems, Inc. has 16 FDA 510(k) clearances (first 1989, latest 2000), across 3 product codes in 1 review panel. Median 510(k) review time: 163 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 8 | 8 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Advanced Spine Fixation Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992012 | WILTSE SYSTEM | KWQ | 2000-02-04 | 234 |
| K990845 | MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 | KWP | 1999-04-13 | 29 |
| K954770 | CENTRA-LINE GRAPPLE, VARIFIX SYSTEM | KWP | 1996-01-25 | 100 |
| K953779 | SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM | MNH | 1995-11-07 | 85 |
| K953778 | SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM | MNH | 1995-11-06 | 84 |
| K953369 | STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW | MNH | 1995-09-08 | 52 |
| K951308 | 5.8MM DIAMETER ANCHOR SCREW | MNH | 1995-07-26 | 126 |
| K951172 | TITANIUM LOW PROFILE CROSS BAR | MNH | 1995-07-25 | 132 |
| K945064 | SELBY INSTRUMENTATION | MNH | 1995-04-26 | 194 |
| K943775 | SELBY INSTRUMENTATION | MNH | 1995-04-26 | 267 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Spine Fixation Systems, 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 Advanced Spine Fixation Systems, Inc. have?
Advanced Spine Fixation Systems, Inc. has 16 FDA 510(k) clearances (first 1989, latest 2000), across 3 product codes in 1 review panel.
How long does FDA take to clear Advanced Spine Fixation Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Spine Fixation Systems, Inc.'s cleared 510(k)s is 163 days.
What devices does Advanced Spine Fixation Systems, Inc. make?
Its most frequent FDA product codes are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 8); KWP (Appliance, Fixation, Spinal Interlaminal, 7); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Has Advanced Spine Fixation Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Spine Fixation Systems, Inc. Related entities may recall under other names.
Next steps
- See all 16 Advanced Spine Fixation Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNH, Advanced Spine Fixation Systems, 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.