510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101835Substantially Equivalent

Medpor Fixation System-Cranial, Models 80080, 80079

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

K101835 is the FDA 510(k) clearance record for MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079, a class II device, cleared for Porex Surgical, Inc. on under FDA product code HBW (Fastener, Plate, Cranioplasty). FDA records list 19 510(k) clearances for Porex Surgical, Inc., from to . As of , FDA records show no recalls naming K101835.

Clearance record

Decision date
Received
(155 days to decision)
Product code
HBW Fastener, Plate, Cranioplasty
Regulation
21 CFR 882.5360
Device class
Class II
Review panel
Neurology
Applicant
Porex Surgical, Inc. 15 Dart Rd., Newnan GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBW

Trailing 12 months

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

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