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FDA 510(k)

TZ SKULL PIN Adult

K-Number: K163322 · 2017-02-23

ApplicantTz Medical, Inc.
Decision Date2017-02-23
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TZ SKULL PIN Adult is a medical device manufactured by Tz Medical, Inc.. It received FDA 510(k) clearance on 2017-02-23 under approval number K163322. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TZ SKULL PIN Adult?

TZ SKULL PIN Adult is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Tz Medical, Inc.. The 510(k) number is K163322.

When was TZ SKULL PIN Adult approved by the FDA?

TZ SKULL PIN Adult received FDA 510(k) clearance on 2017-02-23, under approval number K163322.

What company makes TZ SKULL PIN Adult?

TZ SKULL PIN Adult is manufactured by Tz Medical, Inc..

What is the FDA product code for TZ SKULL PIN Adult?

The FDA product code for TZ SKULL PIN Adult is HBL.

Other Devices by Tz Medical, Inc.

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Related Devices (Code: HBL)

K191701Arcus Head Fixation FrameMri Interventions, Inc. K191979DORO QR3 XTom Headholder SystemPro Med Instruments GmbH K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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