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FDA 510(k)

KNEE BRACE/STABILIZER

K-Number: K802673 · 1980-11-12

ApplicantOmni Scientific, Inc.
Decision Date1980-11-12
Product CodeITQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KNEE BRACE/STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Omni Scientific, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802673. The device is classified under product code ITQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNEE BRACE/STABILIZER?

KNEE BRACE/STABILIZER is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Omni Scientific, Inc.. The 510(k) number is K802673.

When did KNEE BRACE/STABILIZER receive FDA 510(k) clearance?

KNEE BRACE/STABILIZER received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802673.

Who is the listed applicant for KNEE BRACE/STABILIZER?

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

What is the FDA product code for KNEE BRACE/STABILIZER?

The FDA product code for KNEE BRACE/STABILIZER is ITQ.

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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Related Devices (Code: ITQ)

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.

K831044LIMITED MOTION FUNCTIONAL KNEE BRACEOrthopedic Systems, Inc.K831310BRACE C.T.Innovation Sports, Inc.K823658DELUXE KNEE IMMOBILIZER(UNIVERSAL)Warm & Form, Orthopedic MaterialsK823397ANATOMIC FRACTURE BRACEOrthopedic Systems, Inc.K823159DELUXE KNEE IMMOBILIZERWarm & Form, Orthopedic MaterialsK812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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