510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K201676Substantially Equivalent

Barricaid Instrument Tray

Intrinsic Therapeutics, Inc., Woburn MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201676 is the FDA 510(k) clearance record for Barricaid Instrument Tray, a class II device, cleared for Intrinsic Therapeutics, Inc. on under FDA product code QHG (Defect Measurement Tool). FDA's definition for product code QHG reads: "Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the...". FDA records list one 510(k) clearance for Intrinsic Therapeutics, Inc. As of , FDA records show no recalls naming K201676.

Clearance record

Decision date
Received
(27 days to decision)
Product code
QHG Defect Measurement Tool
Regulation
21 CFR 888.4510
Device class
Class II
Review panel
Orthopedic
Applicant
Intrinsic Therapeutics, Inc. 30 Commerce Way, Woburn MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QHG

Trailing 12 months

FDA records hold no clearances under product code QHG in the trailing twelve months.

FDA records show no clearances under product code QHG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QHG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260