510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862279Substantially Equivalent

Expendaguide Multiple Hip Pinning Guide System

Orthospec, Inc., Spring Valley NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862279 is the FDA 510(k) clearance record for EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM, a class II device, cleared for Orthospec, Inc. on under FDA product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component). FDA records list one 510(k) clearance for Orthospec, Inc. As of , FDA records show no recalls naming K862279.

Clearance record

Decision date
Received
(39 days to decision)
Product code
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Orthospec, Inc. 500 Airport Executive Park, Spring Valley NY
Third party review
No

Clearances, product code KTW

Trailing 12 months

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

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