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FDA 510(k)

7D Surgical System

K-Number: K192140 · 2019-11-05

Applicant7D Surgical, Inc.
Decision Date2019-11-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

7D Surgical System 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 2019-11-05 under 510(k) number K192140. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7D Surgical System?

7D Surgical System is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K192140.

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

7D Surgical System received FDA 510(k) clearance on 2019-11-05, under 510(k) number K192140.

Who is the listed applicant for 7D Surgical System?

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?

The FDA product code for 7D Surgical System is OLO.

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 ApplicationK1832767D Surgical System

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Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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