Abbott Spine, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Abbott Spine, Inc.” (first 2005, latest 2009), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| JDQ | Cerclage, Fixation | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| KNW | Instrument, Biopsy | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
Most recent Abbott Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090060 | NEXLINK OCT SYSTEM, MODEL 7000 SERIES | KWP | 2009-06-02 | 144 |
| K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) | NKB | 2008-10-06 | 81 |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | JDQ | 2008-08-29 | 80 |
| K073202 | ARDIS SPACER | MAX | 2008-01-30 | 78 |
| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES | NKB | 2007-11-28 | 68 |
| K071174 | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS | NKB | 2007-07-25 | 89 |
| K062505 | NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES | MNI | 2006-09-26 | 29 |
| K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES | MNI | 2006-03-31 | 22 |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | JDQ | 2006-03-06 | 62 |
| K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY | MNI | 2006-01-06 | 109 |
3 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2008-04-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Spine, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Abbott Spine, Inc.” (first 2005, latest 2009), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Abbott Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Spine, Inc. is 68 days.
Which FDA product codes appear under Abbott Spine, Inc.?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3); JDQ (Cerclage, Fixation, 2).
Next steps
- See all 13 Abbott Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNI, Abbott Spine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.