510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K112470Substantially Equivalent

2Gc Hip/knee Modular Spacer

Mandell Horwitz Consultants, LLC, Fairfax VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112470 is the FDA 510(k) clearance record for 2GC HIP/KNEE MODULAR SPACER, a class II device, cleared for Mandell Horwitz Consultants, LLC on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list one 510(k) clearance for Mandell Horwitz Consultants, LLC. As of , FDA records show no recalls naming K112470.

Clearance record

Decision date
Received
(223 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Mandell Horwitz Consultants, LLC 2995 Steven Martin Dr., Fairfax VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260