510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934861Substantially Equivalent

Hard Tissue Replacement (Htr) Granular

Poly-Medics,Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934861 is the FDA 510(k) clearance record for HARD TISSUE REPLACEMENT (HTR) GRANULAR, a class II device, cleared for Poly-Medics,Inc. on under FDA product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction). FDA records list 5 510(k) clearances for Poly-Medics,Inc., from to . As of , FDA records show no recalls naming K934861.

Clearance record

Decision date
Received
(388 days to decision)
Product code
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Poly-Medics,Inc. P.O. Box 587, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code KKY

Trailing 12 months

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

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