510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844637Substantially Equivalent

Whiteside Acrylic Cement Spacer Sleeve

Dow Corning Corp. Healthcare Industries Materials, P.O. Box 1767 Midland MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844637 is the FDA 510(k) clearance record for WHITESIDE ACRYLIC CEMENT SPACER SLEEVE, a class III device, cleared for Dow Corning Corp. Healthcare Industries Materials on under FDA product code LTC (Hyaline Membrane Disease Assay). FDA records list 31 510(k) clearances for Dow Corning Corp. Healthcare Industries Materials, from to . As of , FDA records show no recalls naming K844637.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LTC Hyaline Membrane Disease Assay
Device class
Class III
Review panel
Unknown
Applicant
Dow Corning Corp. Healthcare Industries Materials
Third party review
No

Clearances, product code LTC

Trailing 12 months

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

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