510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802558Substantially Equivalent

Surcan Knee Holding Device

Bend Orthopedic & Fracture Clinic, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802558 is the FDA 510(k) clearance record for SURCAN KNEE HOLDING DEVICE, a class I device, cleared for Bend Orthopedic & Fracture Clinic 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 one 510(k) clearance for Bend Orthopedic & Fracture Clinic. As of , FDA records show no recalls naming K802558.

Clearance record

Decision date
Received
(15 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
Bend Orthopedic & Fracture Clinic 803 N. Front St. Suite 3, Mchenry IL
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