510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895198Substantially Equivalent

Hall Versipower Surgical Instrument System

Zimmer GmbH, `Anta Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895198 is the FDA 510(k) clearance record for HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM, a class I device, cleared for Zimmer, Inc. on under FDA product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K895198.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Zimmer, Inc. P.O. Box 899, `Anta Barbara CA
Third party review
No

Clearances, product code HWE

Trailing 12 months

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

FDA records show no clearances under product code HWE in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HWE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260