Highridge Medical, LLC: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Highridge Medical, LLC” (first 2025, latest 2025), plus 3 PMA decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 |
|---|---|---|
| 2025 | 2 | 72 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Highridge Medical, LLC took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 67 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | 3 | 0 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Highridge Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253093 | Vital Spinal Fixation System | NKB | 2025-12-17 | 85 |
| K250332 | Virage® OCT Spinal Fixation System | NKG | 2025-04-04 | 58 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120024 | PMA | ACTIVL ARTIFICIAL DISC | 2015-06-11 |
| P110009 | PMA | MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) | 2013-08-23 |
| P110002 | PMA | MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) | 2013-08-07 |
Recalls
openFDA lists no recalls under a recalling firm named Highridge Medical, 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.
Device clinical trials
An industry sponsor named Highridge Medical, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06485206: Evaluation of Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine. (Recruiting, started 2024-09-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Highridge Medical, LLC?
FDA lists 2 510(k) clearances under the applicant name “Highridge Medical, LLC” (first 2025, latest 2025), plus 3 PMA decisions, 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 Highridge Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Highridge Medical, LLC is 72 days.
Which FDA product codes appear under Highridge Medical, LLC?
The most frequent FDA product codes under this applicant name are MJO (Prosthesis, Intervertebral Disc, 3); NKB (Thoracolumbosacral Pedicle Screw System, 1); NKG (Posterior Cervical Screw System, 1).
Next steps
- See all 2 Highridge Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code MJO, Highridge Medical, 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.