510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991588Substantially Equivalent

Ems Swiss Orthoclast

(Ems Sa) Electro Medical Systems, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991588 is the FDA 510(k) clearance record for EMS SWISS ORTHOCLAST, a class I device, cleared for (Ems Sa) Electro Medical Systems on under FDA product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment). FDA records list 5 510(k) clearances for (Ems Sa) Electro Medical Systems, from to . As of , FDA records show no recalls naming K991588.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
(Ems Sa) Electro Medical Systems 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code HSZ

Trailing 12 months

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

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