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FDA 510(k)

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K112748 · 2012-07-11

ApplicantSpinal USA, LLC
Decision Date2012-07-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA, LLC. It received FDA 510(k) clearance on 2012-07-11 under 510(k) number K112748. 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 SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM?

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-11. The listed applicant is Spinal USA, LLC. The 510(k) number is K112748.

When did SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2012-07-11, under 510(k) number K112748.

Who is the listed applicant for SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Spinal USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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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

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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