FDA applicant
Intrinsic Therapeutics
FDA records 3 decisions for Intrinsic Therapeutics (Woburn, MA) from 2007 to 2020: 2 510(k) clearances and 1 original PMA approval. Most are in product codes QES (Reherniation Reduction Device) and JDR (Staple, Fixation, Bone). 1 recall is linked to its devices.
FDA’s records also spell it “Intrinsic Therapeutics Incorporated”, “Intrinsic Therapeutics, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Intrinsic Therapeutics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Intrinsic Therapeutics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Intrinsic”
FDA records each applicant name separately; these may or may not be the same firm.