Altus Partners, LLC: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Altus Partners, LLC” (first 2013, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 160 days, against 90 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 100 |
| 2014 | 0 | — |
| 2015 | 1 | 120 |
| 2016 | 0 | — |
| 2017 | 6 | 117 |
| 2018 | 2 | 46 |
| 2019 | 2 | 188 |
| 2020 | 1 | 113 |
| 2021 | 2 | 222 |
| 2022 | 2 | 418 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 185 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Altus Partners, LLC took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (18)
Most recent Altus Partners, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243419 | Altus Spine Navigation System | OLO | 2025-05-08 | 185 |
| K211027 | Altus Spine Pedicle Screw System | NKB | 2022-09-16 | 528 |
| K211837 | Altus Spine Interbody Standalone Fusion System | OVD | 2022-04-19 | 309 |
| K210887 | Altus Spine Sochi OCT Spinal System | NKG | 2021-08-20 | 148 |
| K200922 | Altus Spine HA Pedicle Screw System | NKB | 2021-01-26 | 295 |
| K200322 | Altus Spine Pedicle Screw System | NKB | 2020-06-02 | 113 |
| K183084 | Fuji Cervical Plate System | KWQ | 2019-05-29 | 204 |
| K182406 | Altus Spine Interbody Fusion System | MAX | 2019-02-22 | 171 |
| K181339 | Altus Spine Pedicle Screw System | NKB | 2018-07-24 | 64 |
| K181281 | Altus Spine Pedicle Screw System | NKB | 2018-06-11 | 27 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Altus Partners, LLC.
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.
- Altus Medical, Inc. (6 510(k)s)
- Altus Spine (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Altus Partners, LLC?
FDA lists 18 510(k) clearances under the applicant name “Altus Partners, LLC” (first 2013, latest 2025), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Altus Partners, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Altus Partners, LLC is 134 days. Since 2017: 160 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Altus Partners, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 6); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 18 Altus Partners, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, Altus Partners, LLC'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.