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FDA 510(k)

Premia Spine XL Instruments

K-Number: K191854 · 2019-10-08

ApplicantPremia Spine, Ltd.
Decision Date2019-10-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Premia Spine XL Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191854. 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 Premia Spine XL Instruments?

Premia Spine XL Instruments is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Premia Spine, Ltd.. The 510(k) number is K191854.

When did Premia Spine XL Instruments receive FDA 510(k) clearance?

Premia Spine XL Instruments received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191854.

Who is the listed applicant for Premia Spine XL Instruments?

The FDA 510(k) record lists Premia Spine, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premia Spine XL Instruments?

The FDA product code for Premia Spine XL Instruments is OLO.

Other records listing Premia Spine, Ltd. 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.

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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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