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FDA 510(k)

SPINE COIL

K-Number: K123708 · 2013-04-10

ApplicantUsa Paramed Medical Systems, Inc.
Decision Date2013-04-10
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPINE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Usa Paramed Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-04-10 under 510(k) number K123708. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE COIL?

SPINE COIL is a medical device that received FDA 510(k) clearance on 2013-04-10. The listed applicant is Usa Paramed Medical Systems, Inc.. The 510(k) number is K123708.

When did SPINE COIL receive FDA 510(k) clearance?

SPINE COIL received FDA 510(k) clearance on 2013-04-10, under 510(k) number K123708.

Who is the listed applicant for SPINE COIL?

The FDA 510(k) record lists Usa Paramed Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINE COIL?

The FDA product code for SPINE COIL is MOS.

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Related Devices (Code: MOS)

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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