510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960307Substantially Equivalent

Index Shoe

Orthopedic Technology Research, Inc., Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960307 is the FDA 510(k) clearance record for INDEX SHOE, a class II device, cleared for Orthopedic Technology Research, Inc. on under FDA product code IRN (Device, Warning, Overload, External Limb, Powered). FDA records list 2 510(k) clearances for Orthopedic Technology Research, Inc., from to . As of , FDA records show no recalls naming K960307.

Clearance record

Decision date
Received
(157 days to decision)
Product code
IRN Device, Warning, Overload, External Limb, Powered
Regulation
21 CFR 890.5575
Device class
Class II
Review panel
Physical Medicine
Applicant
Orthopedic Technology Research, Inc. 819 W. Stryker Ave., Sacramento CA
510(k) summary
Summary
Third party review
No

Clearances, product code IRN

Trailing 12 months

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

FDA records show no clearances under product code IRN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IRN, 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