510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003618Substantially Equivalent

Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model Bio-1-1014

Whiteside Biomechanics, Inc., Creve Coeur MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003618 is the FDA 510(k) clearance record for WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014, a class II device, cleared for Whiteside Biomechanics, Inc. on under FDA product code NDD (Cerclage, Fixation, Metallic). FDA records list 24 510(k) clearances for Whiteside Biomechanics, Inc., from to . As of , FDA records show no recalls naming K003618.

Clearance record

Decision date
Received
(182 days to decision)
Product code
NDD Cerclage, Fixation, Metallic
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Whiteside Biomechanics, Inc. 12634 Olive Blvd., Creve Coeur MO
510(k) summary
Summary
Third party review
No

Clearances, product code NDD

Trailing 12 months

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

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