510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K083621Substantially Equivalent

Medpor Customized Surgical Implant

Porex Surgical, Inc., Newnan GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083621 is the FDA 510(k) clearance record for MEDPOR CUSTOMIZED SURGICAL IMPLANT, a class II device, cleared for Porex Surgical, Inc. on under FDA product code JOF (Polymer, Ent Synthetic, Porous Polyethylene). FDA records list 19 510(k) clearances for Porex Surgical, Inc., from to . As of , FDA records show no recalls naming K083621.

Clearance record

Decision date
Received
(57 days to decision)
Product code
JOF Polymer, Ent Synthetic, Porous Polyethylene
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Porex Surgical, Inc. 15 Dart Rd., Newnan GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOF

Trailing 12 months

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

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