510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931682Substantially Equivalent for Some Indications

Cannulated Malleolar Screw

Onyx Medical LLC, Memphis TN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K931682 is the FDA 510(k) clearance record for CANNULATED MALLEOLAR SCREW, a class II device, cleared for Onyx Medical Corp. on under FDA product code KWK (Appliance, Nail/Blade/Plate Combination, Single Component). FDA records list 48 510(k) clearances for Onyx Medical Corp., from to . As of , FDA records show no recalls naming K931682.

Clearance record

Decision date
Received
(365 days to decision)
Product code
KWK Appliance, Nail/Blade/Plate Combination, Single Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Onyx Medical Corp. 152 Collins St., Memphis TN
Third party review
No

Clearances, product code KWK

Trailing 12 months

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

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