510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861822Substantially Equivalent

Malis Surgical Mesh for Skull /Spinal Column Repai

Valley Forge Scientific Corp., Valley Forge PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861822 is the FDA 510(k) clearance record for MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI, a class II device, cleared for Valley Forge Scientific Corp. on under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable). FDA records list 27 510(k) clearances for Valley Forge Scientific Corp., from to . As of , FDA records show no recalls naming K861822.

Clearance record

Decision date
Received
(60 days to decision)
Product code
GWO Plate, Cranioplasty, Preformed, Alterable
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Applicant
Valley Forge Scientific Corp. P.O. Box 925, Valley Forge PA
Third party review
No

Clearances, product code GWO

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