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FDA 510(k)

7D Surgical System Cranial Application

K-Number: K181041 · 2018-08-08

Applicant7D Surgical, Inc.
Decision Date2018-08-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

7D Surgical System Cranial Application is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K181041. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7D Surgical System Cranial Application?

7D Surgical System Cranial Application is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K181041.

When did 7D Surgical System Cranial Application receive FDA 510(k) clearance?

7D Surgical System Cranial Application received FDA 510(k) clearance on 2018-08-08, under 510(k) number K181041.

Who is the listed applicant for 7D Surgical System Cranial Application?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System Cranial Application?

The FDA product code for 7D Surgical System Cranial Application is HAW.

Other records listing 7D Surgical, 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.

K2205227D Surgical System - Percutaneous Application (7D Flash Frame)K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & KeyK2105557D Surgical System - Drill GuideK2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex ArrayK1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement ApplicationK1921407D Surgical System

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Related Devices (Code: HAW)

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.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

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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