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FDA 510(k)

TSolution One Surgical System Model 210

K-Number: K170430 · 2017-03-06

ApplicantTHINK Surgical, Inc.
Decision Date2017-03-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TSolution One Surgical System Model 210 is the device name listed in this FDA 510(k) record. The listed applicant is THINK Surgical, Inc.. It received FDA 510(k) clearance on 2017-03-06 under 510(k) number K170430. 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 TSolution One Surgical System Model 210?

TSolution One Surgical System Model 210 is a medical device that received FDA 510(k) clearance on 2017-03-06. The listed applicant is THINK Surgical, Inc.. The 510(k) number is K170430.

When did TSolution One Surgical System Model 210 receive FDA 510(k) clearance?

TSolution One Surgical System Model 210 received FDA 510(k) clearance on 2017-03-06, under 510(k) number K170430.

Who is the listed applicant for TSolution One Surgical System Model 210?

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

What is the FDA product code for TSolution One Surgical System Model 210?

The FDA product code for TSolution One Surgical System Model 210 is OLO.

Other records listing THINK Surgical, Inc. as applicant

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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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