510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961101Substantially Equivalent

Stryker Cement Removal System

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961101 is the FDA 510(k) clearance record for STRYKER CEMENT REMOVAL SYSTEM, a class II device, cleared for Stryker Corp. on under FDA product code LZV (System, Cement Removal Extraction). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K961101.

Clearance record

Decision date
Received
(118 days to decision)
Product code
LZV System, Cement Removal Extraction
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Corp. 2725 Fairfield Rd., Kalamazoo MI
510(k) summary
Summary
Third party review
No

Clearances, product code LZV

Trailing 12 months

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

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