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FDA 510(k)

ANATOMIC FRACTURE BRACE

K-Number: K823397 · 1982-11-29

ApplicantOrthopedic Systems, Inc.
Decision Date1982-11-29
Product CodeITQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANATOMIC FRACTURE BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823397. 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 ANATOMIC FRACTURE BRACE?

ANATOMIC FRACTURE BRACE is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K823397.

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

ANATOMIC FRACTURE BRACE received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823397.

Who is the listed applicant for ANATOMIC FRACTURE BRACE?

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

What is the FDA product code for ANATOMIC FRACTURE BRACE?

The FDA product code for ANATOMIC FRACTURE BRACE 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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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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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 MaterialsK823159DELUXE KNEE IMMOBILIZERWarm & Form, Orthopedic MaterialsK812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, Inc.K812094AIRCAST PNEUMATIC KNEE BRACEAircast, 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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