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VSP PEEK Host Skull Model

by 3D Systems, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816847022859 UDI-DI Date10 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vsp Peek
Generic Name
Cranioplasty plate, non-alterable
Model / Reference
Host Skull Model
Description
provided as a guide , to determine the orientation and examine the fitment of the implant on the cranial defect prior to surgery
Primary DI / UDI-DI
00816847022859
510(k) Number
FDA Product Code
GWO
GMDN Term
Cranioplasty plate, non-alterable
Device Class
Class II
Regulation Number
882.5320
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K231834)

Other devices from 3D Systems, Inc.

See all devices from 3D Systems, Inc. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No