510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870844Substantially Equivalent

Schultz Prosthesis Component Inserter Extractor

Warsaw Orthopedic, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870844 is the FDA 510(k) clearance record for SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR, a class I device, cleared for Warsaw Orthopedic, Inc. on under FDA product code HWB (Extractor). FDA records list 24 510(k) clearances for Warsaw Orthopedic, Inc., from to . As of , FDA records show no recalls naming K870844.

Clearance record

Decision date
Received
(10 days to decision)
Product code
HWB Extractor
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Warsaw Orthopedic, Inc. P.O. Box 1157, Warsaw IN
Third party review
No

Clearances, product code HWB

Trailing 12 months

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

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