Intrinsic Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Intrinsic Therapeutics, Inc.” (first 2020, latest 2020), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 27 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 |
|---|---|---|
| 2020 | 1 | 27 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intrinsic Therapeutics, Inc. took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 27 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QES | Reherniation Reduction Device | 1 | 0 |
| QHG | Defect Measurement Tool | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Intrinsic Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201676 | Barricaid Instrument Tray | QHG | 2020-07-16 | 27 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160050 | PMA | BARRICAID ANULAR CLOSURE DEVICE (ACD) | 2019-02-08 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2024-07-25.
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 Intrinsic Therapeutics, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01534065: Barricaid EU Post Market Study for Primary Lumbar Disc Herniation (Completed, started 2009-04)
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.
- Intrinsic Medical Imaging (1 510(k)s)
- Intrinsic Therapeutics Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intrinsic Therapeutics, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Intrinsic Therapeutics, Inc.” (first 2020, latest 2020), plus 1 PMA decision, across 2 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 Intrinsic Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intrinsic Therapeutics, Inc. is 27 days.
Which FDA product codes appear under Intrinsic Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are QES (Reherniation Reduction Device, 1); QHG (Defect Measurement Tool, 1).
Next steps
- See all 1 Intrinsic Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QES, Intrinsic Therapeutics, 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.