510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K071637Substantially Equivalent

Intrinsic Therapeutics Fixation Staple

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

K071637 is the FDA 510(k) clearance record for INTRINSIC THERAPEUTICS FIXATION STAPLE, a class II device, cleared for Intrinsic Therapeutics Incorporated on under FDA product code JDR (Staple, Fixation, Bone). FDA records list one 510(k) clearance for Intrinsic Therapeutics Incorporated. As of , FDA records show no recalls naming K071637.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Intrinsic Therapeutics Incorporated 30 Commerce Way, Woburn MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDR

Trailing 12 months
2 clearances under product code JDR in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260