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FDA 510(k)

ExactechGPS Total Shoulder Application, Equinoxe Planning Software

K-Number: K162567 · 2017-04-05

ApplicantBlue Ortho
Decision Date2017-04-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ortho. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K162567. 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 ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Blue Ortho. The 510(k) number is K162567.

When did ExactechGPS Total Shoulder Application, Equinoxe Planning Software receive FDA 510(k) clearance?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software received FDA 510(k) clearance on 2017-04-05, under 510(k) number K162567.

Who is the listed applicant for ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

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

What is the FDA product code for ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

The FDA product code for ExactechGPS Total Shoulder Application, Equinoxe Planning Software is OLO.

Other records listing Blue Ortho 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.

K233299ExactechGPS® SystemK232521ExactechGPS® Total Ankle ApplicationK213877ExactechGPS® SystemK213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareK193618ExactechGPS SystemK173372ExactechGPS Total Shoulder Application

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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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