510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070012Substantially Equivalent

Polybone

Kyung Won Medical Co., Ltd., Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070012 is the FDA 510(k) clearance record for POLYBONE, a class II device, cleared for Kyung Won Medical Co., Ltd. on under FDA product code GXP (Methyl Methacrylate For Cranioplasty). FDA records list 4 510(k) clearances for Kyung Won Medical Co., Ltd., from to . As of , FDA records show no recalls naming K070012.

Clearance record

Decision date
Received
(358 days to decision)
Product code
GXP Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Kyung Won Medical Co., Ltd. 13340 E Firestone Blvd., Santa Fe Springs CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXP

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