Chrysalis Intelligence · Sponsors · Intrinsic Therapeutics, Inc.

Intrinsic Therapeutics, Inc.

Woburn, MA, US · 1 510(k) clearances · 9 PMAs · 2 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
1
2020-07-16 → 2020-07-16
Last 12 months
0
Product codes
1
Most recent
2020-07-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QHG Defect Measurement Tool Class II Orthopedic 1 2020-07-16
Class III

PMA approvals (9)

Total PMA records
9
Originals + supplements
Distinct product codes
1
First decision
2020-03-17
Most recent
2026-03-24
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-03-24 P160050-S012 Barricaid® Annular Closure Device 30-Day Notice QES Reherniation Reduction Device Unknown
2025-12-18 P160050-S011 Barricaid® Annular Closure Device 30-Day Notice QES Reherniation Reduction Device Unknown
2025-10-09 P160050-S010 Barricaid® Annular Closure Device Normal 180 Day Track QES Reherniation Reduction Device Unknown
2024-07-03 P160050-S009 Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb 30-Day Notice QES Reherniation Reduction Device Unknown
2024-02-08 P160050-S008 Barricaid® Annular Closure Device 30-Day Notice QES Reherniation Reduction Device Unknown
2023-08-25 P160050-S007 Barricaid® Annular Closure Device 30-Day Notice QES Reherniation Reduction Device Unknown
2020-05-19 P160050-S006 Barricaid Annular Closure Device Normal 180 Day Track No User Fee QES Reherniation Reduction Device Unknown
2020-05-12 P160050-S005 Barricaid Annular Closure Device Normal 180 Day Track No User Fee QES Reherniation Reduction Device Unknown
2020-03-17 P160050-S003 Barricaid Anular Closure Device (ACD) Real-Time Process QES Reherniation Reduction Device Unknown
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
1
Most recent
2024-07-25
DateSeverityStatusRecall # ProductCodeReason
2024-07-25 Class II Ongoing Z-2688-2024 Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A — At least two units have been found to be missing a weld.
2020-07-24 Class II Terminated Z-2798-2020 Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incid… — 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 BA…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-07-16 K201676 Barricaid Instrument Tray QHG Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence