Life Spine, Inc.: FDA clearances and approvals
Life Spine, Inc. has 123 FDA 510(k) clearances (first 2004, latest 2026), across 21 product codes in 1 review panel. Median 510(k) review time: 91 days. Since 2017 its median was 85 days, against 91 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 182 |
| 2013 | 7 | 91 |
| 2014 | 5 | 91 |
| 2015 | 10 | 106 |
| 2016 | 6 | 190 |
| 2017 | 10 | 84 |
| 2018 | 10 | 138 |
| 2019 | 7 | 92 |
| 2020 | 9 | 66 |
| 2021 | 6 | 101 |
| 2022 | 5 | 85 |
| 2023 | 4 | 112 |
| 2024 | 3 | 42 |
| 2025 | 3 | 57 |
| 2026 | 5 | 89 |
Review time against the same product codes
Since 2017, Life Spine, Inc.'s cleared 510(k)s took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 33 | 33 |
| NKB | Thoracolumbosacral Pedicle Screw System | 22 | 22 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 14 | 14 |
| MNI | Orthosis, Spinal Pedicle Fixation | 7 | 7 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 5 |
| OUR | Sacroiliac Joint Fixation | 5 | 5 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| NKG | Posterior Cervical Screw System | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
Plus 11 more product codes.
Review panels
- Orthopedic (123)
Most recent Life Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261430 | TruLift Expandable System | MAX | 2026-07-28 | 89 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | OLO | 2026-06-02 | 103 |
| K260837 | VersaLift Expandable System | MAX | 2026-05-12 | 60 |
| K254274 | ARx® SAI Implant System | NKB | 2026-04-16 | 107 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | MAX | 2026-01-23 | 59 |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | MAX | 2025-07-07 | 53 |
| K250373 | ProLift Expandable Spacer System | MAX | 2025-04-09 | 58 |
| K243668 | ProLift Pivot Expandable Spacer System | MAX | 2025-01-23 | 57 |
| K243369 | Cervical Plating System | KWQ | 2024-12-11 | 42 |
| K242826 | ProLift Wedge Expandable Spacer System | MAX | 2024-10-08 | 20 |
113 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life Spine, 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 Life Spine, Inc. have?
Life Spine, Inc. has 123 FDA 510(k) clearances (first 2004, latest 2026), across 21 product codes in 1 review panel.
How long does FDA take to clear Life Spine, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Life Spine, Inc.'s cleared 510(k)s is 91 days. Since 2017: 85 days, versus 91 days for all cleared 510(k)s in the same product codes.
What devices does Life Spine, Inc. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 33); NKB (Thoracolumbosacral Pedicle Screw System, 22); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 14).
Has Life Spine, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Life Spine, Inc. Related entities may recall under other names.
Next steps
- See all 123 Life Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Life Spine, 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.