510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K110684Substantially Equivalent

Medcad Accushape (Tm) Peek Patient Specific Cranial / Craniofacial Implant

Vanduzen dba Medcad, Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110684 is the FDA 510(k) clearance record for MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT, a class II device, cleared for Vanduzen Dba Medcad on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list one 510(k) clearance for Vanduzen Dba Medcad. As of , FDA records show no recalls naming K110684.

Clearance record

Decision date
Received
(105 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Vanduzen Dba Medcad 1201 Richardson, Richardson TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXN

Trailing 12 months
6 clearances under product code GXN in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GXN, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260