510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861566Substantially Equivalent

Slr Bipolar Hip Endoprosthesis

Dow Corning Wright, Arlington TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861566 is the FDA 510(k) clearance record for SLR BIPOLAR HIP ENDOPROSTHESIS, a class II device, cleared for Dow Corning Wright on under FDA product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented). FDA records list 74 510(k) clearances for Dow Corning Wright, from to . As of , FDA records show no recalls naming K861566.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Regulation
21 CFR 888.3390
Device class
Class II
Review panel
Orthopedic
Applicant
Dow Corning Wright P.O. Box 100, Arlington TN
Third party review
No

Clearances, product code KWY

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