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FDA 510(k)

LUMBAR FLEXION BRACE

K-Number: K810554 · 1981-03-13

ApplicantOrthomedics
Decision Date1981-03-13
Product CodeIPY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LUMBAR FLEXION BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Orthomedics. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810554. 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 LUMBAR FLEXION BRACE?

LUMBAR FLEXION BRACE is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Orthomedics. The 510(k) number is K810554.

When did LUMBAR FLEXION BRACE receive FDA 510(k) clearance?

LUMBAR FLEXION BRACE received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810554.

Who is the listed applicant for LUMBAR FLEXION BRACE?

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

What is the FDA product code for LUMBAR FLEXION BRACE?

The FDA product code for LUMBAR FLEXION BRACE is IPY.

Related Clinical Trials

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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Other records listing Orthomedics 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.

K832741JASON CERVICAL ORTHOSISK832742EXTENSION CONTROL KNEE ORTHOSISK832740FEMORAL FRACTURE ORTHOSISK811456ORTHO-FRAC KITK811297CERVICAL SUPPORTK811298EXECUTIVE COLLAR

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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 ConsultantsK823823LUMBOSACRAL SUPPORTDanek Medical, Inc.K812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISSurgical Appliance Industries, Inc.K812099CASH ORTHOSISDavid Hendricks, C.P.O.K811494LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.K810556SPINAL 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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