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FDA 510(k)

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

K-Number: K031576 · 2003-07-31

ApplicantSurgitech, Inc.
Decision Date2003-07-31
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Surgitech, Inc.. It received FDA 510(k) clearance on 2003-07-31 under 510(k) number K031576. 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 SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1?

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 is a medical device that received FDA 510(k) clearance on 2003-07-31. The listed applicant is Surgitech, Inc.. The 510(k) number is K031576.

When did SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 receive FDA 510(k) clearance?

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 received FDA 510(k) clearance on 2003-07-31, under 510(k) number K031576.

Who is the listed applicant for SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1?

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

What is the FDA product code for SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1?

The FDA product code for SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 is IQI.

Related Clinical Trials

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Other records listing Surgitech, Inc. 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.

K033358CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000

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 LPK926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, Inc.K831615DROP FOOT BRACEEdward Dilauro, Jr.

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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