TZ SKULL PIN Adult

FDA 510(k) K163322 · Tz Medical, Inc.

Substantially Equivalent

510(k) numberK163322

Submission

Device name
TZ SKULL PIN Adult
Applicant
Tz Medical, Inc.
Portland, OR, US
Received
November 25, 2016
Decision date
February 23, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

Other 510(k)s with product code HBL

510(k)DeviceApplicantDecision
K250423mb-FIX Cranial Stabilization SystemsHBL · Traditional Medical Bees GmbH11/06/2025SE
K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special Pro Med Instruments GmbH07/26/2024SE
K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional Pro Med Instruments GmbH04/24/2024SE
K203505DORO QR3 Headrest System (Aluminum)HBL · Traditional Pro Med Instruments GmbH03/29/2021SE
K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional Pro Med Instruments GmbH06/02/2020SE
K191740DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional Pro Med Instruments GmbH02/21/2020SE
K191701Arcus Head Fixation FrameHBL · Traditional Mri Interventions, Inc.11/15/2019SE
K191979DORO QR3 XTom Headholder SystemHBL · Traditional Pro Med Instruments GmbH10/22/2019SE
K142238MAYFIELD Skull ClampHBL · Traditional Integra LifeSciences Corporation11/24/2014SE
K141950HFD100 Rocker Arm AccessoryHBL · Special Imris, Inc.09/04/2014SE

More from Imris, Inc.

510(k)DeviceDecision
K252772Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional 05/22/2026SE
K173563Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional 01/10/2018SE
K102507Area-Ct, TZ Medical Mcot ECG Monitor and Arrhythmia DetectorDSI · Abbreviated 06/13/2011SE
K062577V1 Multi-Port Connector, Model Pad V1-MPCDSA · Traditional 12/15/2006SE
K040208Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandQSY · Traditional 05/11/2004SE
K021421Padtac Electrophysiology Recording Catheters, Junction Cable Connector & CableDRF · Traditional 04/18/2003SE
K001634Cardiosentry Event Monitor, Model 8470-01DXH · Traditional 12/21/2000SE
K993205Booker Box, Model Pad 5010LDD · Traditional 07/20/2000SE
K983232Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional 09/15/1999SE
K983196Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional 09/15/1999SE

Questions and answers

When was TZ SKULL PIN Adult cleared by the FDA?

TZ SKULL PIN Adult (K163322) received a 510(k) decision of Substantially Equivalent on February 23, 2017, 90 days after the submission was received.

What is the product code of K163322?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.