510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151285Substantially Equivalent

VSP Cranial System

3D Systems, Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151285 is the FDA 510(k) clearance record for VSP Cranial System, a class II device, cleared for 3D Systems, Inc. on under FDA product code PPT (Cranial Surgical Planning And Instrument Guides). FDA's definition for product code PPT reads: "Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures". FDA records list 17 510(k) clearances for 3D Systems, Inc., from to . As of , FDA records show no recalls naming K151285.

Clearance record

Decision date
Received
(498 days to decision)
Product code
PPT Cranial Surgical Planning And Instrument Guides
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
3D Systems, Inc. 17301 W. Colfax Ave., Golden CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PPT

Trailing 12 months
1 clearance under product code PPT in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260