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FDA 510(k)

LUMBOSACRAL SUPPORT

K-Number: K823823 · 1983-01-14

ApplicantDanek Medical, Inc.
Decision Date1983-01-14
Product CodeIPY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LUMBOSACRAL SUPPORT is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823823. The device is classified under product code IPY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMBOSACRAL SUPPORT?

LUMBOSACRAL SUPPORT is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Danek Medical, Inc.. The 510(k) number is K823823.

When did LUMBOSACRAL SUPPORT receive FDA 510(k) clearance?

LUMBOSACRAL SUPPORT received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823823.

Who is the listed applicant for LUMBOSACRAL SUPPORT?

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

What is the FDA product code for LUMBOSACRAL SUPPORT?

The FDA product code for LUMBOSACRAL SUPPORT is IPY.

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Other records listing Danek Medical, Inc. as applicant

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Related Devices (Code: IPY)

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.

K823882M-BRACEBuckman ConsultantsK812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISSurgical Appliance Industries, Inc.K812099CASH ORTHOSISDavid Hendricks, C.P.O.K811494LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.K810554LUMBAR FLEXION BRACEOrthomedicsK810556SPINAL EXTENSION BRACEOrthomedics

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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