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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 the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) 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. The listed applicant is Tz Medical, Inc.. The 510(k) number is K163322.

When did TZ SKULL PIN Adult receive FDA 510(k) clearance?

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

Who is the listed applicant for TZ SKULL PIN Adult?

The FDA 510(k) record lists Tz Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Tz Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HBL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbHK241883DORO 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 GmbHK240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbHK203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbHK193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbHK191740DORO LUCENT® iXI and iMRI Headrest SystemPro 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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