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FDA 510(k)

TIBIAL FRACTURE BRACE

K-Number: K802871 · 1980-12-11

ApplicantOrthomedics
Decision Date1980-12-11
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TIBIAL FRACTURE BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Orthomedics. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802871. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIBIAL FRACTURE BRACE?

TIBIAL FRACTURE BRACE is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Orthomedics. The 510(k) number is K802871.

When did TIBIAL FRACTURE BRACE receive FDA 510(k) clearance?

TIBIAL FRACTURE BRACE received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802871.

Who is the listed applicant for TIBIAL FRACTURE 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 TIBIAL FRACTURE BRACE?

The FDA product code for TIBIAL FRACTURE BRACE is IQI.

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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.

K832742EXTENSION CONTROL KNEE ORTHOSISK832741JASON CERVICAL ORTHOSISK832740FEMORAL FRACTURE ORTHOSISK811456ORTHO-FRAC KITK811298EXECUTIVE COLLARK811297CERVICAL SUPPORT

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Related Devices (Code: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, Inc.

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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