Integrity Implants, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Integrity Implants, Inc.” (first 2019, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 126 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 |
|---|---|---|
| 2019 | 3 | 135 |
| 2020 | 3 | 90 |
| 2021 | 2 | 170 |
| 2022 | 2 | 100 |
| 2023 | 1 | 111 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Integrity Implants, Inc. took a median 126 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Integrity Implants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231098 | LineSider® Spinal System | NKB | 2023-08-07 | 111 |
| K213355 | Toro-L Interbody Fusion System | MAX | 2022-03-25 | 164 |
| K220453 | FlareHawk Interbody Fusion System | MAX | 2022-03-24 | 35 |
| K212088 | Integrity Implants Navigated Instruments | OLO | 2021-12-23 | 170 |
| K203038 | Toro-L Interbody Fusion System | MAX | 2021-03-26 | 171 |
| K203367 | LineSider Spinal System | NKB | 2020-12-03 | 17 |
| K202198 | FlareHawk Interbody Fusion System | MAX | 2020-11-03 | 90 |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | MAX | 2020-09-23 | 124 |
| K190360 | LineSider Spinal System | NKB | 2019-06-21 | 126 |
| K183184 | FlareHawk Interbody Fusion System | MAX | 2019-04-03 | 135 |
1 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 4 recall events; 5 initiated in the last five years. Most recent: 2024-12-20.
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.
Device clinical trials
An industry sponsor named Integrity Implants, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04057235: Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion (Completed, started 2019-09-23)
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.
- Integrity Optics, Inc. (2 510(k)s)
- Integrity Spine (2 510(k)s)
- Integrity Implants Inc. Dba Accelus (1 510(k)s)
- Integrity Life Sciences (1 510(k)s)
- Integrity Medical Software, Inc. (1 510(k)s)
- Integrity Orthopaedics, Inc. (1 510(k)s)
- Integrity Practice Management, Inc. (1 510(k)s)
- Integrity Spine Lumbar Interbody Fusion System (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Integrity Implants, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Integrity Implants, Inc.” (first 2019, latest 2023), across 3 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 Integrity Implants, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Integrity Implants, Inc. is 126 days. Since 2017: 126 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Integrity Implants, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7); NKB (Thoracolumbosacral Pedicle Screw System, 3); OLO (Orthopedic Stereotaxic Instrument, 1).
Next steps
- See all 11 Integrity Implants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Integrity Implants, 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.