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FDA 510(k)

ANTERIOR BUTTRESS PLATE

K-Number: K081548 · 2009-01-29

ApplicantScient'X USA, Inc.
Decision Date2009-01-29
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTERIOR BUTTRESS PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X USA, Inc.. It received FDA 510(k) clearance on 2009-01-29 under 510(k) number K081548. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTERIOR BUTTRESS PLATE?

ANTERIOR BUTTRESS PLATE is a medical device that received FDA 510(k) clearance on 2009-01-29. The listed applicant is Scient'X USA, Inc.. The 510(k) number is K081548.

When did ANTERIOR BUTTRESS PLATE receive FDA 510(k) clearance?

ANTERIOR BUTTRESS PLATE received FDA 510(k) clearance on 2009-01-29, under 510(k) number K081548.

Who is the listed applicant for ANTERIOR BUTTRESS PLATE?

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

What is the FDA product code for ANTERIOR BUTTRESS PLATE?

The FDA product code for ANTERIOR BUTTRESS PLATE is KWQ.

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Other records listing Scient'X USA, Inc. 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.

K080588SCIENT'X TRIBECA VBRK053292DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTSK031290MODIFICATION TO EASYS TRANSVERSE CONNECTION

Related Devices (Code: KWQ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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