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FDA 510(k)

SCOLIOSIS ORTHOTIC SYSTEM

K-Number: K810555 · 1981-03-13

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

Device Summary

SCOLIOSIS ORTHOTIC SYSTEM 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 K810555. The device is classified under product code IQF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOLIOSIS ORTHOTIC SYSTEM?

SCOLIOSIS ORTHOTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Orthomedics. The 510(k) number is K810555.

When did SCOLIOSIS ORTHOTIC SYSTEM receive FDA 510(k) clearance?

SCOLIOSIS ORTHOTIC SYSTEM received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810555.

Who is the listed applicant for SCOLIOSIS ORTHOTIC SYSTEM?

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 SCOLIOSIS ORTHOTIC SYSTEM?

The FDA product code for SCOLIOSIS ORTHOTIC SYSTEM is IQF.

Related Clinical Trials

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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: IQF)

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 ORTHOSISOrthomedicsK812342ZEE EXTRICATION DEVICEZee Medical Products Co., Inc.K811297CERVICAL SUPPORTOrthomedicsK791350POPE AMBULATORY HALO VESTHospital Products Co.K781761KENDRICK EXTRICATION DEVICEMedi-Ked, Inc.K780489SPINE BOARDMarullo, Baldwin, Frieden, Gatewood,

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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