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FDA 510(k)

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS

K-Number: K033109 · 2004-03-23

ApplicantScient'X
Decision Date2004-03-23
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X. It received FDA 510(k) clearance on 2004-03-23 under 510(k) number K033109. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS?

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS is a medical device that received FDA 510(k) clearance on 2004-03-23. The listed applicant is Scient'X. The 510(k) number is K033109.

When did ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS receive FDA 510(k) clearance?

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS received FDA 510(k) clearance on 2004-03-23, under 510(k) number K033109.

Who is the listed applicant for ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS?

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

What is the FDA product code for ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS?

The FDA product code for ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS is MQP.

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Other records listing Scient'X 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.

K071261ISOBAR SEMI-RIGID DUAL DAMPENERK062912SCIENT'X SPINAL SYSTEMK052763STELLA CERVICAL PLATEK052367SCIENT'X CEMENT RESTRICTORK050348CO VERTEBRAL BODY REPLACEMENTK051063POLYAXIAL HEMISPHERICAL SPINAL SCREWS

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Related Devices (Code: MQP)

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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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