510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002586Substantially Equivalent

Medpor Pterional Surgical Implant

Porex Surgical Products Group, Newnan GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002586 is the FDA 510(k) clearance record for MEDPOR PTERIONAL SURGICAL IMPLANT, a class II device, cleared for Porex Surgical Products Group on under FDA product code MNF (Implant, Temporal). FDA records list one 510(k) clearance for Porex Surgical Products Group. As of , FDA records show no recalls naming K002586.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MNF Implant, Temporal
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Porex Surgical Products Group 15 Dart Rd., Newnan GA
510(k) summary
Summary
Third party review
No

Clearances, product code MNF

Trailing 12 months

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

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