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FDA 510(k)

SeaSpine 7D Navigation Instruments

K-Number: K222753 · 2022-12-09

ApplicantSeaSpine Orthopedics Corporation
Decision Date2022-12-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SeaSpine 7D Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222753. 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 SeaSpine 7D Navigation Instruments?

SeaSpine 7D Navigation Instruments is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K222753.

When did SeaSpine 7D Navigation Instruments receive FDA 510(k) clearance?

SeaSpine 7D Navigation Instruments received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222753.

Who is the listed applicant for SeaSpine 7D Navigation Instruments?

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

What is the FDA product code for SeaSpine 7D Navigation Instruments?

The FDA product code for SeaSpine 7D Navigation Instruments is OLO.

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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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