510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853186Substantially Equivalent

Silastic Inflatable Bone Plug H.p.

Dow Corning Corp. Healthcare Industries Materials, Hemlock MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853186 is the FDA 510(k) clearance record for SILASTIC INFLATABLE BONE PLUG H.P., a class II device, cleared for Dow Corning Corp. Healthcare Industries Materials on under FDA product code LZN (Cement Obturator). FDA records list 31 510(k) clearances for Dow Corning Corp. Healthcare Industries Materials, from to . As of , FDA records show no recalls naming K853186.

Clearance record

Decision date
Received
(56 days to decision)
Product code
LZN Cement Obturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Dow Corning Corp. Healthcare Industries Materials Technical Service & Developmen, Hemlock MI
Third party review
No

Clearances, product code LZN

Trailing 12 months

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

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