510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973614Substantially Equivalent

Foundation Unipolar Femoral Head with Modular Neck Length Sleeves

Encore Orthopedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973614 is the FDA 510(k) clearance record for FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES, a class II device, cleared for Encore Orthopedics, Inc. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 85 510(k) clearances for Encore Orthopedics, Inc., from to . As of , FDA records show no recalls naming K973614.

Clearance record

Decision date
Received
(86 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Encore Orthopedics, Inc. 9800 Metric Blvd., Austin TX
510(k) summary
Summary
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