510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910031Substantially Equivalent

Park City Shoulder Positioner

Mizuho Orthopedic Systems Inc, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910031 is the FDA 510(k) clearance record for PARK CITY SHOULDER POSITIONER, a class I device, cleared for Orthopedic Systems, Inc. on under FDA product code FWZ (Operating Room Accessories Table Tray). FDA's definition for product code FWZ reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K910031.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FWZ Operating Room Accessories Table Tray
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Orthopedic Systems, Inc. 1897 National Ave., Hayward CA
Third party review
No

Clearances, product code FWZ

Trailing 12 months

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

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