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FDA 510(k)

HIP7

K-Number: K193307 · 2020-06-02

ApplicantBrainlab AG
Decision Date2020-06-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HIP7 is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K193307. 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 HIP7?

HIP7 is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Brainlab AG. The 510(k) number is K193307.

When did HIP7 receive FDA 510(k) clearance?

HIP7 received FDA 510(k) clearance on 2020-06-02, under 510(k) number K193307.

Who is the listed applicant for HIP7?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIP7?

The FDA product code for HIP7 is OLO.

Related Clinical Trials

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NCT05891002Accuracy of Robotically Assisted Cranial BiopsiesTERMINATED

Other records listing Brainlab AG 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: 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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