510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K151692Substantially Equivalent

BioArchitects Patient Specific Cranial/Craniofacial Plate

Bioarchitects USA, LLC, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151692 is the FDA 510(k) clearance record for BioArchitects Patient Specific Cranial/Craniofacial Plate, a class II device, cleared for Bioarchitects USA, LLC on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list one 510(k) clearance for Bioarchitects USA, LLC. As of , FDA records show no recalls naming K151692.

Clearance record

Decision date
Received
(150 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Bioarchitects USA, LLC 219 E. 69th St., New York NY
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