Data / Medical devices / United States / Intrinsic Therapeutics, Inc.
Intrinsic Therapeutics, Inc.: FDA-registered device maker in Woburn, MA, United States, 1 510(k) clearance and 1 PMA approval
Intrinsic Therapeutics, Inc. is registered with the FDA (registration 3006232063) in Woburn, MA, United States. It lists 5 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 16, 2020. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006232063
- Address
- 30 Commerce Way, Woburn, MA, United States, 01801
- Owner or operator
- Intrinsic Therapeutics Inc. (10023198)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 25, 2019
- Registered through
- 2027
- Brand names listed
- Barricaid, Extractor, Extractor Weight, Impactor, Intrsument Tray / Defect Mesurement Tool for Barricaid Annular Closure Device, Narrow Barricaid, Nerve Root Retractor, Suction, Removal Tool and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Defect Measurement Tool | QHG | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Reherniation Reduction Device | QES | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2020 | K201676 | Barricaid Instrument Tray | QHG | Substantially Equivalent | Intrinsic Therapeutics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 8, 2019 | P160050 | BARRICAID ANULAR CLOSURE DEVICE (ACD) | QES | 11 | March 24, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 25, 2024 | 95066 | Class II | Ongoing | Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A | At least two units have been found to be missing a weld. | accessdata.fda.gov |
| July 24, 2020 | 86121 | Class II | Terminated | Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or witho | The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM. | accessdata.fda.gov |
Compare with other makers
Updated March 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.